Home NDC 0172-4097 Baclofen
Product NDC 0172-4097
11-digit product format 001724097
Labeler code 0172
Product ID 0172-4097_ba227be6-e946-423c-a9a6-e0626d889ea7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197391 Internal RxNorm lookup 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 0172-4097-60 Baclofen 100 in 1 BOTTLE TABLET 100 19 0172-4097-80 Baclofen 1000 in 1 BOTTLE TABLET 1000 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 12 BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.] 12 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 12 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.] 12 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 12 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.] 12 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.] 12 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.] 12 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.] 12 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 12 BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.] 4 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.] 4 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.] 4 Baclofen ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.] 2 Baclofen ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.] 2 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.] 2 Baclofen ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [UNIT DOSE SERVICES] 1 Baclofen ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [REBEL DISTRIBUTORS CORP] 1 Baclofen ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [REBEL DISTRIBUTORS CORP] 1 Baclofen ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [UNIT DOSE SERVICES] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BACLOFEN TABLET [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BACLOFEN TABLET [UNIT DOSE SERVICES] 1 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP BACLOFEN TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [UNIT DOSE SERVICES] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [UNIT DOSE SERVICES] 1 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP BACLOFEN TABLET [UNIT DOSE SERVICES] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [UNIT DOSE SERVICES] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BACLOFEN TABLET [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BACLOFEN TABLET [UNIT DOSE SERVICES] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0172-4097 BACLOFEN TABLET [TEVA PHARMACEUTICALS USA, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20210518_5648c772-50cb-4961-996e-e68a8eb699ea.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 0172-4097-60 00172409760 100 TABLET in 1 BOTTLE (0172-4097-60) 100 tablet 1988-07-21 0000-00-00 No No Current 0172-4097-80 00172409780 1000 TABLET in 1 BOTTLE (0172-4097-80) 1000 tablet 1988-08-01 0000-00-00 No No Current