Home NDC 80425-0080 Baclofen
Product NDC 80425-0080
11-digit product format 804250080
Labeler code 80425
Product ID 80425-0080_2a9914d0-6557-747c-e063-6294a90a946c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler Advanced Rx of Tennessee, LLC
Application ANDA072234
Marketing category ANDA
Marketing start 1988-07-21
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072234-001 BACLOFEN BACLOFEN 10MG TABLET / ORAL AB 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 A072234-001 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 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 1988-07-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072234-001 BACLOFEN 10MG TABLET / ORAL AB 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 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 80425-0080-2 Baclofen 60 in 1 BOTTLE TABLET 60 7 80425-0080-3 Baclofen 90 in 1 BOTTLE TABLET 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0080 BACLOFEN TABLET [ADVANCED RX OF TENNESSEE, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20250101_b33c4164-e607-2e27-e053-2a95a90ad7db.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Baclofen BACLOFEN Northwind Health Company, LLC 06bcfb08-2ada-f803-e063-6394a90a826b 2025-12-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 072234 application number: ANDA072234 Baclofen BACLOFEN PD-Rx Pharmaceuticals, Inc. 95755a7b-4a9f-45ea-a381-d3f661150efe 2025-10-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 072234 application number: ANDA072234 Baclofen BACLOFEN Advanced Rx of Tennessee, LLC b33c4164-e607-2e27-e053-2a95a90ad7db 2024-12-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 072234 application number: ANDA072234 ndc (product): 80425-0080 Baclofen BACLOFEN Proficient Rx LP b981eb16-a195-41da-a186-3e91b63b2def 2024-10-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 072234 application number: ANDA072234 Baclofen BACLOFEN Teva Pharmaceuticals USA, Inc. 5648c772-50cb-4961-996e-e68a8eb699ea 2019-12-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 072234 application number: ANDA072234
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 80425-0080-2 80425008002 60 TABLET in 1 BOTTLE (80425-0080-2) 60 tablet 1988-07-21 0000-00-00 No No Current 80425-0080-3 80425008003 90 TABLET in 1 BOTTLE (80425-0080-3) 90 tablet 1988-07-21 0000-00-00 No No Current