Home NDC 50090-7559 buprenorphine hydrochloride
Product NDC 50090-7559
11-digit product format 500907559
Labeler code 50090
Product ID 50090-7559_18fa8a54-6196-4635-a213-f78a9236f3d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buprenorphine hydrochloride
Dosage form TABLET
Route SUBLINGUAL
Labeler A-S Medication Solutions
Application ANDA090622
Marketing category ANDA
Marketing start 2023-10-12
Substance BUPRENORPHINE HYDROCHLORIDE
Active strength 8 mg/1
Pharmacologic classes Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A090622-001 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 A090622-002 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24
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 · 84 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 2026-08-18 06:07:40 2026-07 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090622-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2010-09-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090622-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2010-09-24 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base buprenorphine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPRENORPHINE HYDROCHLORIDE 8 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351265 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-7559-0 buprenorphine hydrochloride 30 in 1 BOTTLE TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-7559 BUPRENORPHINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] 1 Current NDC, 1 package rows 20250529_c1398d85-d4bb-4426-8ecf-a50400910d81.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-7559-0 50090755900 30 TABLET in 1 BOTTLE (50090-7559-0) 30 tablet 2025-05-27 No No Current