Last updated: June 2, 2026
HYDROCODONE bitartrate and acetaminophen combination drug supply chains typically bifurcate into (1) opioid API and (2) acetaminophen API, with finished dosage manufacturers then sourcing one or both upstream inputs and manufacturing tablets or capsules under DEA/controlled-substance handling requirements. However, no supplier-identifying information (company names, facility locations, DMFs, Orange Book listings, labeled strengths, NDCs, or product titles) is provided here, so a complete and accurate supplier list cannot be produced.
What suppliers provide hydrocodone bitartrate and acetaminophen in the US?
A credible supplier answer requires mapping specific finished products (by NDC/labeler) to their underlying drug substances and manufacturing sites (by DMF/letter of authorization, Orange Book NDA/BLA records, and facility registrations). Without those identifiers, any list would be incomplete and risks factual errors.
What upstream entities typically supply hydrocodone bitartrate?
Hydrocodone bitartrate is a controlled opioid. Upstream supply is usually concentrated among firms with:
- DEA registrations for the relevant schedule handling
- validated API manufacturing lines
- established DMF coverage for hydrocodone bitartrate
What upstream entities typically supply acetaminophen?
Acetaminophen API supply is broader than opioids and includes:
- API manufacturers with capabilities for acetaminophen crystallization/polymorph control
- DMF-covered manufacturers supporting multiple generic and branded downstream tablets/capsules
Which companies manufacture hydrocodone bitartrate and acetaminophen tablets or capsules?
Finished dosage manufacturing for this opioid combination is tied to specific product labels and strengths (for example, 5 mg/325 mg, 7.5 mg/300 mg, 10 mg/325 mg, 10 mg/650 mg, and others). Supplier identification requires:
- the labeled product record (NDA/ANDA) and manufacturer name(s)
- Orange Book “Applicants” and “Manufacturers/Labelers”
- contract manufacturing disclosures where available
Without NDCs or specific strengths, a supplier-to-product mapping cannot be generated.
How does supplier availability differ by strength (5/325 vs 10/650) and dosage form?
Hydrocodone/acetaminophen supply risk can vary by:
- strength-specific procurement of hydrocodone bitartrate batches
- tablet vs capsule production line constraints
- packaging components and controlled-substance storage/transport handling
But strength and dosage-form specifics are required to make this concrete for business planning.
What Orange Book listings identify suppliers for hydrocodone bitartrate and acetaminophen?
Orange Book listings tie:
- NDA/ANDA to the labeled drug products
- active ingredients to the application
- sometimes to listed manufacturing locations
A supplier list must be derived from the Orange Book records for the specific hydrocodone/acetaminophen combination entries. No application identifiers are supplied.
What API DMFs cover hydrocodone bitartrate and acetaminophen?
DMFs typically reveal upstream suppliers through:
- DMF holder names
- LOA networks to downstream ANDA/NDA applicants
- facility addresses tied to the DMF
No DMF numbers or NDA/ANDA entries are provided, so supplier identification by DMF is not possible here.
What contract manufacturers (CMOs) support hydrocodone/acetaminophen combination products?
Contract manufacturing capacity depends on controlled-substance compliance, which is not inferable without:
- target finished product
- labeled manufacturer (or applicant/labeler) identity
- facility details or inspection signals
No target product identity is given.
Key supply-chain constraints for hydrocodone/acetaminophen
For planning, the operational constraints are generally:
- controlled substance registration and DEA compliance for opioid handling
- GMP batch release and supply continuity for both opioid and analgesic inputs
- diversion-control and audit requirements through storage, packaging, and shipping
- line clearance and cross-contamination controls across opioid products
But supplier-specific availability requires product- and facility-level mapping.
Key Takeaways
- A supplier list for HYDROCODONE BITARTRATE AND ACETAMINOPHEN cannot be produced accurately from the information provided.
- Supplier identification for this combination requires specific finished product identifiers (NDC, NDA/ANDA, labeled strength/dosage form) and/or upstream file mapping (Orange Book, DMFs, LOAs).
- Controlled-substance handling is a gating factor for hydrocodone bitartrate API and finished dosage manufacturing, but it does not replace the need for product-specific records.
FAQs
Which manufacturers make generic hydrocodone bitartrate and acetaminophen?
A product-specific Orange Book/NDC mapping is required to name manufacturers reliably.
How do I identify hydrocodone bitartrate API suppliers?
Use hydrocodone bitartrate DMF holders and LOA networks tied to the specific ANDA/NDA.
Do acetaminophen and hydrocodone use the same API supplier across strengths?
Strengths often use different DMF batch sourcing or different salt-grade lots, but the answer depends on the exact labeled product.
Who supplies hydrocodone/acetaminophen tablets versus capsules?
Supplier set differs by dosage form and by manufacturing line qualification for that label.
What documentation shows the supplier for my exact NDC?
Orange Book for the application plus FDA labeling records for the NDC labeler and, where available, manufacturing site disclosures.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-02).
- FDA. Drug Master Files (DMF) program overview. (Accessed 2026-06-02).
