Home NDC 63187-274 Baclofen
Product NDC 63187-274
11-digit product format 631870274
Labeler code 63187
Product ID 63187-274_8ef3522a-3a22-4d52-852d-a18f5a78f482
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA072235
Marketing category ANDA
Marketing start 1988-07-21
Substance BACLOFEN
Active strength 20 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072235-001 BACLOFEN BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072235-001 AB
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 · 41 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 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072235-001 BACLOFEN 20MG TABLET / ORAL AB RS 1988-07-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 20 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 197392 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 63187-274-30 Baclofen 30 in 1 BOTTLE TABLET 30 5 63187-274-60 Baclofen 60 in 1 BOTTLE TABLET 60 5 63187-274-90 Baclofen 90 in 1 BOTTLE TABLET 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-274 BACLOFEN TABLET [PROFICIENT RX LP] 5 Current NDC, Legacy NDC, 3 package rows 20241024_9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63187-274-30 63187027430 30 TABLET in 1 BOTTLE (63187-274-30) 30 tablet 2014-11-21 0000-00-00 No No Current 63187-274-60 63187027460 60 TABLET in 1 BOTTLE (63187-274-60) 60 tablet 2014-11-21 0000-00-00 No No Current 63187-274-90 63187027490 90 TABLET in 1 BOTTLE (63187-274-90) 90 tablet 2014-11-21 0000-00-00 No No Current