Home NDC 60429-587-30 Buprenorphine and Naloxone
Product NDC 60429-587
Requested package NDC 60429-587-30
11-digit product format 604290587
Labeler code 60429
Product ID 60429-587_e64cb42d-75be-4157-e053-2995a90ab1a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buprenorphine hydrochloride and naloxone hydrochloride
Dosage form TABLET
Route SUBLINGUAL
Labeler Golden State Medical Supply, Inc.
Application ANDA204431
Marketing category ANDA
Marketing start 2015-10-16
Marketing end 2023-09-30
Substance BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active strength 8 mg/1; mg/1
Pharmacologic classes Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule CIII
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204431-001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET / SUBLINGUAL AB 2015-10-16 A204431-002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A204431-001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET / SUBLINGUAL AB 2015-10-16 a50c72e98297…2026-08-01 22:54:32 2026-06 A204431-002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-10-16 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A204431-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A204431-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Buprenorphine and Naloxone BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma d5b011ef-f1be-47f2-8f8b-07553f36193c 2026-02-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 204431 application number: ANDA204431
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60429-587-30 60429058730 30 TABLET in 1 BOTTLE, PLASTIC (60429-587-30) 30 tablet 2016-01-07 2023-09-30 No No Current