Last updated: May 26, 2026
NORPACE (nortriptyline) Suppliers: Active Ingredient, Finished Dosage Forms, Contract Manufacturing, and Distribution
NORPACE is a brand of nortriptyline hydrochloride (a tricyclic antidepressant). Supplier discovery for “NORPACE” is ultimately anchored to (1) the drug substance source of nortriptyline HCl, (2) the finished dosage form (capsules/tablets) manufacturer, and (3) the US distribution network that supports the NDC-labeled product.
No complete, audit-ready supplier map (specific firms tied to NORPACE-labeled NDCs, drug substance DMFs, and contract manufacturing sites) can be produced from the information provided here.
What companies supply nortriptyline hydrochloride used to make NORPACE?
- Drug substance supply for nortriptyline HCl is typically sourced from API manufacturers with active regulatory filings (for US use: DMFs referenced by the finished dosage form holder).
- Finished NORPACE supply is tied to the approved NDA manufacturing and packaging sites for the product’s specific dosage form strengths.
Which companies manufacture NORPACE capsules or tablets for the US market?
- Finished-dose manufacturers are identified by:
- FDA labeling/manufacturing sections tied to NORPACE package inserts,
- Orange Book listings for the NORPACE NDA referencing the approved product,
- NDA chemistry and manufacturing information and supplements (often reflected in labeling and regulatory updates).
How do you identify NORPACE-specific suppliers by NDC and labeler?
A NORPACE “supplier” list that stands up in licensing or procurement diligence is built by matching:
- NDC (11-digit)
- Labeler/manufacturer code (as displayed on the package or FDA product database)
- Dosage form and strength
- Applicant/NDA holder and linked manufacturing site(s)
This avoids mixing nortriptyline HCl API sources with finished-dose packagers that are unrelated to the NORPACE-labeled product.
Where are NORPACE products distributed, and who are the US wholesalers?
- US supply chain “suppliers” for NORPACE typically include:
- the NDA holder or marketing authorization holder,
- the primary wholesaler/distributor network tied to the NDC,
- any authorized re-packagers where applicable.
- Wholesaler participation is NDC- and geography-dependent and is not recoverable from brand-name-only input.
What patents protect NORPACE and how does that affect supplier choices?
Supplier selection for a branded product can be constrained by:
- patent estate (including formulation and method-of-use patents, if any remain active),
- regulatory exclusivities, and
- manufacturing-site approvals for the specific NDA/BLA/ANDA pathway.
NORPACE is not a biologic, so the “biosimilar risk” framing does not apply.
No NORPACE patent and exclusivity mapping can be compiled here without the NORPACE NDA number(s) and the specific dosage form/strength being considered.
How does FDA approval status impact NORPACE sourcing?
To determine whether NORPACE can be sourced via multiple manufacturers, the key items are:
- whether the NDA is held by one applicant with multiple manufacturing sites,
- whether there are authorized generics or multiple approved applicants,
- whether labeling indicates additional packagers or relabelers.
Those items require NORPACE’s FDA product record details (NDA/NDC).
Key Takeaways
- NORPACE supplier identification requires NDC-level linkage to the finished dosage form manufacturer and labeler and, separately, API DMF linkages for nortriptyline HCl.
- Brand-only input is insufficient to produce an actionable list of specific companies tied to NORPACE-labeled product and the regulatory/CMC basis behind their supply.
FAQs
- How do I find the specific NORPACE labeler/manufacturer for a given NDC?
- Do NORPACE suppliers differ by strength or dosage form (capsule vs tablet)?
- What records link nortriptyline HCl API DMFs to NORPACE finished-dose products?
- Can NORPACE be supplied by multiple finished-dose manufacturers under one NDA?
- How do Orange Book listings change the supplier landscape for NORPACE?
References
- FDA Orange Book: Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA National Drug Code Directory. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
- FDA Drug Registration and Listing System (DRLS). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-registration-and-listing-system
