Home NDC 42571-428 Baclofen
Product NDC 42571-428
11-digit product format 425710428
Labeler code 42571
Product ID 42571-428_0acb9150-3e4c-9f37-e063-6294a90a7fd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler Micro Labs Limited
Application ANDA217687
Marketing category ANDA
Marketing start 2024-04-01
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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217687-001 BACLOFEN BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 A217687-002 BACLOFEN BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 A217687-003 BACLOFEN BACLOFEN 20MG TABLET / ORAL AB 2023-11-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2 · 57 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 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217687-002 BACLOFEN 10MG TABLET / ORAL AB 2023-11-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217687-003 BACLOFEN 20MG TABLET / ORAL AB 2023-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217687-001 BACLOFEN 5MG TABLET / ORAL AB 2023-11-08 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42571-428-01 Baclofen 100 in 1 BOTTLE TABLET 100 1 42571-428-05 Baclofen 500 in 1 BOTTLE TABLET 500 1 42571-428-13 Baclofen 1000 in 1 BOTTLE TABLET 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-428 BACLOFEN TABLET [MICRO LABS LIMITED] 1 Current NDC, 3 package rows 20240402_f0abf768-3b19-452b-b56d-eb70441cfb18.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42571-428-01 42571042801 100 TABLET in 1 BOTTLE (42571-428-01) 100 tablet 2024-04-01 No No Historical 42571-428-05 42571042805 500 TABLET in 1 BOTTLE (42571-428-05) 500 tablet 2024-04-01 No No Historical 42571-428-13 42571042813 1000 TABLET in 1 BOTTLE (42571-428-13) 1000 tablet 2024-04-01 No No Historical