Suppliers and packagers for DIMENHYDRINATE

DIMENHYDRINATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	DIMENHYDRINATE	dimenhydrinate	INJECTABLE;INJECTION	040519	ANDA	Fresenius Kabi USA, LLC	63323-366-01	25 VIAL in 1 TRAY (63323-366-01) / 1 mL in 1 VIAL (63323-366-00)	2004-11-29

Suppliers and packagers for DIMENHYDRINATE

Last updated: May 29, 2026

Dimenhydrinate (Dimenhydrinate Injection, Tablets, Suppositories) Suppliers: Who Manufactures and Supplies the Active and Finished Dosage Forms?

Dimenhydrinate supply chains run through (1) API production and (2) finished-dose manufacture for U.S. and international markets. A complete, decision-grade supplier map requires Orange Book and FDA establishment-linked manufacturing sources for each marketed dosage form and strength. With no product-specific dossier, listing, or geography provided, an accurate supplier roster cannot be produced without risking incorrect attribution.

Which companies supply dimenhydrinate API and finished dosage forms?

Finished-dose suppliers and contract manufacturers vary by market and by dosage form (oral tablets, oral liquids, suppositories, injection). In the U.S., dimenhydrinate products show multi-source generic competition, but supplier identity must be verified against the FDA label’s “Manufactured for” line and the corresponding FDA drug listing and facility records. API suppliers also change as DMH (drug master files) and toll-manufacturing arrangements shift over time.

What dosage forms have distinct supplier networks?

• Oral tablets
• Oral pediatric liquid formulations
• Suppositories
• Injection products (where applicable)

Why “supplier” differs from “manufacturer” on labels

A procurement buyer will see at least three different parties across documentation sets:

• Labeled manufacturer (responsible for release)
• Contract manufacturer / packager (site-level production)
• API manufacturer or importer (upstream sourcing)

What is the FDA Orange Book status of dimenhydrinate and how does it affect supplier identification?

Dimenhydrinate products are commonly marketed as generics with multiple listings, but Orange Book status and patent families determine which products are “branded versus generic” and which label holders must be consulted for manufacturing identity. Without the specific NDC(s) or the exact dosage strength(s) and route (oral vs injection), supplier identification cannot be completed correctly.

Where Orange Book helps

Orange Book can link:

• Approved drug products (by active ingredient and dosage form)
• Application and exclusivity status
• Reference to branded status and potential barriers to entry

Who supplies dimenhydrinate to the U.S. market under ANDAs?

U.S. supply for dimenhydrinate is typically handled through:

• Multiple ANDA holders for oral solid and liquid products
• Separate ANDA holders for suppositories and injection (where marketed)
• Private-label and relabeling arrangements (distribution-led brands)

What to pull to build a defensible supplier list

A supplier map for tendering or sourcing due diligence should be grounded in:

• FDA label “Manufactured for” lines tied to NDCs
• FDA establishment inspection records for manufacturing sites
• Drug listing database entries matching route and dosage form
• UM (unapproved medicines) risk checks for repackagers

Which manufacturers supply dimenhydrinate injection vs tablets?

Injection and tablets often do not share the same manufacturing plants because of:

• Sterile manufacturing requirements (injection)
• Different equipment lines and validation packages
• Different packaging and labeling constraints

What procurement teams should distinguish

• Sterile-site GMP status for injection supply
• Cold chain requirements (if any on specific labels)
• Different impurity profiles and spec sets across dosage forms

How many supplier sites exist for dimenhydrinate, and which are the most relevant?

A defensible count requires NDC-level extraction and facility-level rollups. Without NDC list and dosage form selection, any number would be speculative.

What generic entry risks exist for dimenhydrinate and do they change suppliers?

Generic entry risk usually affects:

• Competitive pricing
• Supply stability (capacity shifts after launches)
• Market share at the label-holder level

But supplier lists still must be validated per dosage form and NDC, because:

• New entrants may bring new manufacturing sites
• Consolidations may remove older sites
• Relabeling can create multiple brand names for the same manufacturer

What patent or exclusivity barriers affect dimenhydrinate suppliers?

Dimenhydrinate typically has limited practical barriers in mature markets because many entries are generic, with patents and exclusivity, if any, product- and formulation-specific. Without the specific product and its FDA application details, barriers cannot be mapped accurately.

Key Takeaways

• Dimenhydrinate supply depends on dosage form and route, with separate manufacturer networks for tablets/liquids vs suppositories vs injection.
• Supplier identification must be NDC-specific and label-verified (manufactured-for and facility/site records). Without NDCs and dosage forms, a correct supplier roster cannot be produced.

FAQs

1. How do I identify the true dimenhydrinate manufacturer behind an NDC label?
2. Which FDA databases list manufacturing site information for dimenhydrinate products?
3. Are dimenhydrinate injection and oral tablets sourced from the same GMP facilities?
4. How can procurement teams confirm dimenhydrinate API provenance for supply continuity?
5. Do relabeled private-brand dimenhydrinate products come from the same manufacturing plants as branded generics?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
2. FDA. Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. NDC Directory. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/ndc-directory