FDA.reportPublic FDA data

Buprenorphine and Naloxone

Product NDC
63629-7270
Requested package NDC
63629-7270-1
11-digit product format
636297270
Labeler code
63629
Product ID
63629-7270_2dfda9b4-25d2-4bc8-8a09-cd1e683f05e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine hydrochloride and naloxone hydrochloride
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Bryant Ranch Prepack
Application
ANDA204431
Marketing category
ANDA
Marketing start
2016-01-07
Marketing end
0000-00-00
Substance
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active strength
2 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-727063629-7270-1DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204431-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2015-10-16
A204431-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2015-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A204431-001AB
A204431-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204431-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2015-10-16a50c72e98297…
2026-08-01 22:54:322026-06A204431-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2015-10-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204431-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204431-002AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine and NaloxoneBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharmad5b011ef-f1be-47f2-8f8b-07553f36193c2026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204431
application number: ANDA204431

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7270-12021-01-06C16284748780-19d75b9d0-6f85-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE Sublingual Tablets for sublingual administration CIII Initial U.S. Approval: 2002
63629-7270-22021-01-06C16284748780-19d75b9d0-6f85-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE Sublingual Tablets for sublingual administration CIII Initial U.S. Approval: 2002
63629-7270-12020-01-31C16284748780-19d75b9d0-6f85-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE Sublingual Tablets for sublingual administration CIII Initial U.S. Approval: 2002
63629-7270-22020-01-31C16284748780-19d75b9d0-6f85-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE Sublingual Tablets for sublingual administration CIII Initial U.S. Approval: 2002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7270-16362972700130 TABLET in 1 BOTTLE (63629-7270-1) 30 tablet2022-09-020000-00-00NoNoCurrent