Home NDC 50090-6869 Baclofen
Product NDC 50090-6869
11-digit product format 500906869
Labeler code 50090
Product ID 50090-6869_624a0565-ee42-4f30-a23e-825ae6ae6709
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA074584
Marketing category ANDA
Marketing start 2010-10-20
Substance BACLOFEN
Active strength 10 mg/1
Pharmacologic classes GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
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 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 A074584-001 BACLOFEN BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 A074584-002 BACLOFEN BACLOFEN 20MG TABLET / ORAL AB 1996-08-19
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 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074584-001 BACLOFEN 10MG TABLET / ORAL AB 1996-08-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A074584-002 BACLOFEN 20MG TABLET / ORAL AB 1996-08-19 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 Baclofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACLOFEN 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H789N3FKE8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197391 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 50090-6869-0 Baclofen 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6869 BACLOFEN TABLET [A-S MEDICATION SOLUTIONS] 1 Current NDC, 1 package rows 20231207_e163e7dc-45a5-43c2-b13d-a4453f2c360c.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 50090-6869-0 50090686900 90 TABLET in 1 BOTTLE (50090-6869-0) 90 tablet 2023-12-04 No No Current