Suppliers and packagers for AMBIEN

AMBIEN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908	NDA	Sanofi-Aventis U.S. LLC	0024-5401-31	100 TABLET, FILM COATED in 1 BOTTLE (0024-5401-31)	1993-04-01
Cosette	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908	NDA	Sanofi-Aventis U.S. LLC	0024-5421-31	100 TABLET, FILM COATED in 1 BOTTLE (0024-5421-31)	1993-04-01
Cosette	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908	NDA	Cosette Pharmaceuticals, Inc.	0713-5401-01	100 TABLET, FILM COATED in 1 BOTTLE (0713-5401-01)	2025-02-07
Cosette	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908	NDA	Cosette Pharmaceuticals, Inc.	0713-5421-01	100 TABLET, FILM COATED in 1 BOTTLE (0713-5421-01)	2025-02-07

Suppliers for AMBIEN (zolpidem) APIs, Finished Dosage Manufacturers, and Distribution Partners in the U.S.

Last updated: May 26, 2026

AMBIEN is the brand for zolpidem tartrate immediate-release tablets (historically 5 mg and 10 mg). Supplier mapping for AMBIEN splits into (1) zolpidem active pharmaceutical ingredient (API) producers, (2) finished-dose tablet manufacturers for the approved U.S. NDA product, and (3) downstream distribution and repackaging channels that populate the U.S. supply chain.

What suppliers make the zolpidem API used in AMBIEN?

AMBIEN’s active ingredient is zolpidem tartrate. The API supply chain typically involves large-scale fine-chemical producers supplying global generic and brand registrants. For the AMBIEN brand specifically, the most reliable supplier identification in practice comes from a combination of:

• FDA Drug Master File (DMF) holder names referenced in Orange Book and NDA manufacturing disclosures
• Current Good Manufacturing Practice (cGMP) site listings tied to the NDA manufacturer on the FDA label
• Public API procurement visibility via DMF correspondences (when disclosed) and inspection outcomes

API supplier list (U.S. AMBIEN brand-specific): not available from the provided inputs.

Which DMF holders commonly supply zolpidem API into the U.S. market?

Zolpidem API is a well-established chemical for immediate-release and ER (extended-release) variants. DMF holders vary by strength, salt form (tartrate), and the registrant’s chosen synthetic route and impurity control strategy.

DMF holder names for AMBIEN’s NDA are not provided in the input material.

What finished-dose manufacturers produce AMBIEN tablets?

AMBIEN tablets are manufactured under the product’s NDA and distributed under the brand label. Finished-dose manufacturing sites are typically shown on the FDA-approved package insert (label) and/or manufacturing section of the approved product listing.

AMBIEN specific finished-dose manufacturers and cGMP sites: not available from the provided inputs.

How do AMBIEN tablet manufacturing supply chains work?

The finished-dose supply chain usually includes:

• API receipt and tartrate salt confirmation
• Milling, blending, and tablet compression
• Coating (if applicable by strength)
• In-process controls and finished product release testing
• Packaging line ownership and label control for the brand market

Because tablet press and packaging lines can shift with commercial supply needs, the most defensible approach is NDA-linked site disclosure.

Who is the U.S. distributor for AMBIEN?

A brand’s U.S. distribution chain typically includes:

• The NDA holder’s commercial group
• Wholesalers that carry the product across major channels
• Pharmacy benefit and specialty distribution networks in some cases

Distributor names for AMBIEN are not provided in the input material.

What wholesalers typically handle zolpidem brands?

U.S. wholesaling is dominated by national distributors and their regional affiliates. However, AMBIEN channel-by-channel allocation is operational and contract-based, so a generic “wholesaler list” would not identify the AMBIEN-specific distribution counterparties for the brand.

What is the Orange Book and label-based path to identify AMBIEN suppliers?

Supplier identification for a branded NDA product is most defensible when built from FDA sources that link:

• The approved dosage form and strength
• The applicant/holder
• The listed manufacturer(s) and packaging sites on label sections

Orange Book vs. label: where supplier data appears?

• Orange Book: drug product listing plus applicant information, often indirectly reflecting manufacturing/tech transfer status
• FDA label (package insert): usually contains “Manufactured for” and address blocks for the sponsor/manufacturer and sometimes the actual manufacturing site

No Orange Book entry data or label text is provided in the input material.

How does AMBIEN compare with generic zolpidem tablet suppliers?

Generic zolpidem immediate-release tablets are widely manufactured by multiple firms across global sites. This creates a different supplier set than the brand’s original NDA manufacturing. In commercial practice, the biggest near-term supply exposure for investors and litigators is often not the brand’s API origin but the controlling generic manufacturers and their ability to run through demand spikes.

A supplier-comparison table for AMBIEN versus generic zolpidem suppliers is not available from the provided inputs.

Which supplier categories matter most for exclusivity and supply continuity?

For AMBIEN, the supply continuity risk is tied to:

• Availability of zolpidem tartrate API from the chosen synthetic route
• Ability of the selected tablet-manufacturer sites to maintain dissolution and impurity specs
• Packaging line readiness for NDC-specific configurations

No NDC-specific supplier mapping is provided in the input material.

What supplier risks exist for AMBIEN (API shortages, recalls, and QC failures)?

Supply risk is measurable through:

• FDA enforcement actions affecting manufacturing sites
• Recalls involving tablet content uniformity, dissolution, impurity, or packaging mix-ups
• Batch failures linked to blend uniformity or coating/durability

No FDA enforcement, recall, or inspection dataset is provided in the input material.

How to interpret supplier risk in zolpidem tablet supply?

Zolpidem is a controlled substance in the U.S., and distribution and documentation controls add operational friction. Supplier disruption can surface as:

• Backorders and allocation through wholesalers
• Package size or NDC configuration shortages
• Switching among secondary suppliers and contract manufacturers

Without company-site evidence, a supplier risk list cannot be generated from the provided inputs.

What are the most actionable next steps to identify AMBIEN suppliers from public records?

A complete AMBIEN supplier map in the U.S. should be anchored to the product label and FDA submissions. The typical workflow is:

1. Extract the NDA holder and “Manufactured for” and manufacturing/distribution addresses from the AMBIEN package insert.
2. Identify the FDA-listed manufacturing site(s) for the AMBIEN tablets.
3. Cross-reference the API DMF holder(s) linked to the NDA submission materials when publicly visible.
4. Map NDCs to package configuration to confirm which tablet/packaging plants are active for each NDC.

Those label and Orange Book inputs are not included in the provided material, so a factual supplier list cannot be produced.

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Key Takeaways

• AMBIEN’s drug substance is zolpidem tartrate and its U.S. supplier set is determined by NDA-linked API and finished-dose manufacturing sites plus the U.S. distribution counterparty network.
• The specific AMBIEN API producers, finished-dose manufacturers, and distributors cannot be enumerated from the provided inputs.
• Supplier identification that stands up in licensing, litigation, or procurement decisions requires label- and FDA-listed manufacturer/site data tied to the AMBIEN NDA and NDCs.

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FAQs

1) How can I find the exact contract manufacturing site for AMBIEN tablets?
Use the FDA-approved package insert “Manufactured for” and manufacturing address blocks tied to each AMBIEN strength and NDC.

2) What API form does AMBIEN use, and does it affect supplier eligibility?
AMBIEN uses zolpidem tartrate; suppliers must control impurities and polymorph/salt form consistent with the NDA specifications.

3) Are the API suppliers for brand AMBIEN the same as those for generic zolpidem tablets?
Not necessarily; brand registrants and generic applicants can use different DMF holders and synthesis routes even when the API molecule is the same.

4) What supply chain documents best support AMBIEN supplier due diligence?
Label manufacturing sections, NDC-level product listings, DMF-linked references where visible, and FDA site inspection/enforcement records.

5) What drives AMBIEN supply disruptions in practice?
API availability, manufacturing site capacity for tablet/dissolution specs, packaging line readiness, and controlled-substance distribution constraints.

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References

1. U.S. Food and Drug Administration (FDA). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA. Prescribing Information for AMBIEN (zolpidem tartrate) tablets.