Home NDC 72888-510-01 buprenorphine hydrochloride
Product NDC 72888-510
Requested package NDC 72888-510-01
11-digit product format 728880510
Labeler code 72888
Product ID 72888-510_56cc7ad7-e846-8168-e063-6294a90a336d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buprenorphine hydrochloride
Dosage form TABLET
Route SUBLINGUAL
Labeler Advagen Pharma Ltd
Application ANDA090279
Marketing category ANDA
Marketing start 2026-02-01
Substance BUPRENORPHINE HYDROCHLORIDE
Active strength 12 mg/1
Pharmacologic classes Partial Opioid Agonist [EPC]; Partial Opioid Agonists [MoA]
DEA schedule CIII
Listing certified through 2027-12-31
Current FDA listing Yes 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 A090279-001 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 A090279-002 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10
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.
Product history page 1 of 3 · 82 observed 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 2026-02-19 14:30 UTC 2026-02 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090279-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-06-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090279-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-06-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base buprenorphine hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPRENORPHINE HYDROCHLORIDE 12 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 56W8MW3EN1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351264 Internal RxNorm lookup 351265 Internal RxNorm lookup 2747481 Internal RxNorm lookup 2747482 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 72888-510-01 72888051001 30 TABLET in 1 BOTTLE (72888-510-01) 30 tablet 2026-07-10 0 Current