NDC product

Buprenorphine HCl

NDC 0406-7018 · SpecGx LLC

Key facts

Product NDC 0406-7018
Proprietary name Buprenorphine HCl
Nonproprietary name Buprenorphine HCl
Substances BUPRENORPHINE HYDROCHLORIDE
Dosage form TABLET
Route SUBLINGUAL
Labeler SpecGx LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA218473
DEA schedule CIII
Pharmacologic classes Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
Marketing start Jan 19, 2026
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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