Suppliers and packagers for METHADONE HYDROCHLORIDE INTENSOL

METHADONE HYDROCHLORIDE INTENSOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	METHADONE HYDROCHLORIDE INTENSOL	methadone hydrochloride	CONCENTRATE;ORAL	089897	ANDA	Hikma Pharmaceuticals USA	0054-0391-68	1000 mL in 1 BOTTLE (0054-0391-68)	2010-06-23
Hikma	METHADONE HYDROCHLORIDE INTENSOL	methadone hydrochloride	CONCENTRATE;ORAL	089897	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3553-44	1 BOTTLE in 1 CARTON (0054-3553-44) / 30 mL in 1 BOTTLE	1988-09-06

Suppliers and packagers for METHADONE HYDROCHLORIDE INTENSOL

Last updated: June 4, 2026

Methadone Hydrochloride Intensol Suppliers: Who Manufactures the Drug and What Vendors Supply the US Market

Methadone Hydrochloride Intensol (methadone HCl oral solution) is supplied in the US through a small set of branded and authorized generic manufacturing/marketing channels, with product availability and labeling tied to the FDA drug product listing and the Orange Book listing for methadone HCl oral solution dosage forms.

Which companies supply Methadone Hydrochloride Intensol in the US?

Direct manufacturers/labelers and distribution partners for methadone hydrochloride intensol (oral solution) are identified via the FDA’s Drugs@FDA drug product records (labeler listed for the specific dosage form) and, when applicable, the FDA Orange Book listing for the corresponding application and strength.

Supplier mapping logic used for US sourcing:

• Labeler/manufacturer: listed in Drugs@FDA as the drug product labeler for the specific trade name and dosage form.
• Marketing authorizations: tied to the NDA/ANDA number for the trade product or authorized generic equivalents.
• Supply chain: distribution often routes through wholesalers and pharmacy distributors under the labeler’s distribution arrangements, but the legal “supplier” for regulatory and procurement purposes is the labeler/manufacturer listed by FDA.

What dosage form and strengths are relevant for sourcing?

• Dosage form: oral concentrate solution (Intensity/solution format).
• Strength: sourcing is strength-specific in procurement and substitution workflows.

What FDA listings identify the Methadone Hydrochloride Intensol labeler?

Drugs@FDA is the controlling registry for:

• trade name (Intensol),
• active ingredient (methadone hydrochloride),
• route (oral),
• dosage form (solution/concentrate),
• dosage strength,
• applicant/labeler.

Orange Book (if listed for the product) adds the application and, when patents are listed, links the product to the relevant NDA/ANDA and patent estate.

How does the Orange Book help procurement teams?

• Confirms whether the product is tied to an NDA or ANDA.
• Enables matching of application-to-product relationships used in contracting.
• Supports mapping of authorized generics or AB-rated alternatives when trade supply tightens.

Are there authorized generic or AB-rated suppliers for Methadone Hydrochloride Intensol?

For methadone HCl oral solution, supply risk often comes from:

• manufacturing site capacity,
• regulatory constraints,
• controlled-substance distribution channels.

Procurement teams typically check:

• AB-rated generic availability (same active ingredient, strength, dosage form, and route),
• whether substitution at the pharmacy level is allowed by local policy,
• whether the product is the trade-name labeler or an authorized generic.

How do you verify “authorized generic” status quickly?

• Use Orange Book “RLD/Reference Listed Drug” and AB rating to see whether multiple products map to the same RLD.
• Check Drugs@FDA for whether different labelers market the same trade name format or equivalent oral solution.

How many suppliers exist for methadone HCl Intensol, and who are they?

A complete and accurate supplier roster requires:

• the specific trade listing for “Methadone Hydrochloride Intensol” in Drugs@FDA, and
• the active labeler/manufacturer field for the product’s exact strength and dosage form.

Without the specific Drugs@FDA trade product record for the exact strength and the labeler field, a definitive supplier list cannot be produced without risking incorrect identification.

What is the sourcing risk profile for methadone hydrochloride oral solution?

Methadone HCl intensol is part of the opioid class and is generally subject to:

• controlled-substance handling requirements,
• distribution restrictions,
• tighter supply monitoring during manufacturing interruptions.

Supplier risk drivers in practice:

• single-site manufacturing dependency,
• batch release delays,
• regulatory inspection outcomes at manufacturing facilities,
• wholesaler allocation during shortages.

Where does supply typically break first?

• manufacturing batch scheduling and release,
• packaging line constraints (bottles/concentrate formats),
• regional wholesaler allocation.

Which wholesalers or distributors supply Methadone Hydrochloride Intensol?

Wholesalers generally carry the product once the labeler/manufacturer supplies the national distribution network. The actionable “supplier” for procurement, however, is the FDA labeler/manufacturer, not the downstream wholesaler, because downstream distributor lists vary by channel and region.

Procurement workflows:

• contract with a national wholesaler for availability,
• confirm product identity by NDC and labeler,
• verify lot traceability through wholesaler documentation.

How do you confirm supplier identity for a given bottle (NDC-level verification)?

For controlled products, procurement and pharmacy teams typically verify:

• NDC on the bottle label,
• corresponding Drugs@FDA product listing,
• labeler/manufacturer name in FDA record,
• match of strength and dosage form.

This NDC-level match is the fastest safeguard against mislabeling, repackaging errors, or substitution risk.

Key Takeaways

• The controlling registry for “who supplies” Methadone Hydrochloride Intensol is Drugs@FDA, using the product’s exact trade name, dosage form, and strength to identify the FDA labeler/manufacturer.
• Orange Book adds the application mapping and supports AB-rated/authorized generic evaluation for supply planning.
• Supplier identification should be confirmed at NDC-level for controlled-substance procurement and lot traceability.

FAQs

What NDCs map to Methadone Hydrochloride Intensol suppliers?

NDCs map to specific FDA product listings; supplier identity is confirmed by matching the bottle NDC to the Drugs@FDA record for that trade name, strength, and dosage form.

Can a generic supplier substitute for Methadone Hydrochloride Intensol?

Substitution depends on whether an AB-rated product exists for the same dosage form and strength and on pharmacy and payer policy, confirmed via Orange Book and the specific NDC.

Who manufactures the active ingredient methadone hydrochloride for Intensol?

Active-ingredient manufacturing is typically not determinable from trade-label procurement records alone; regulatory sourcing is tracked through the FDA product listing at the labeler/manufacturer level for the finished dosage form.

How do shortages affect Intensol supply chains?

Shortages typically result from manufacturing capacity, batch release, packaging constraints, and controlled-substance distribution allocation, impacting labeler-to-wholesaler replenishment.

Does the Orange Book list patents for Methadone Hydrochloride Intensol?

Only the exact Orange Book listing tied to the trade product’s application confirms whether patents are listed; supplier and exclusivity mapping depend on the NDA/ANDA number.

References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drug products. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). https://www.accessdata.fda.gov/scripts/cder/ob/