Home NDC 76420-357-01 BACLOFEN
Product NDC 76420-357
Requested package NDC 76420-357-01
11-digit product format 764200357
Labeler code 76420
Product ID 76420-357_3c3b62bc-64f9-f0cb-e063-6394a90a4a92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BACLOFEN
Dosage form TABLET
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA209102
Marketing category ANDA
Marketing start 2018-04-01
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 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209102-001 BACLOFEN BACLOFEN 5MG TABLET / ORAL AB 2017-11-28 A209102-002 BACLOFEN BACLOFEN 10MG TABLET / ORAL AB 2017-11-28 A209102-003 BACLOFEN BACLOFEN 20MG TABLET / ORAL AB 2017-11-28 A209102-004 BACLOFEN BACLOFEN 15MG TABLET / ORAL AB 2024-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 4 · 148 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 2026-09-14 22:38:34 2026-08 A209102-001 BACLOFEN 5MG TABLET / ORAL AB 2017-11-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209102-002 BACLOFEN 10MG TABLET / ORAL AB 2017-11-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209102-003 BACLOFEN 20MG TABLET / ORAL AB 2017-11-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209102-004 BACLOFEN 15MG TABLET / ORAL AB 2024-02-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209102-001 BACLOFEN 5MG TABLET / ORAL AB 2017-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209102-002 BACLOFEN 10MG TABLET / ORAL AB 2017-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209102-003 BACLOFEN 20MG TABLET / ORAL AB 2017-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209102-004 BACLOFEN 15MG TABLET / ORAL AB 2024-02-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209102-001 BACLOFEN 5MG TABLET / ORAL AB 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209102-002 BACLOFEN 10MG TABLET / ORAL AB 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209102-003 BACLOFEN 20MG TABLET / ORAL AB 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209102-004 BACLOFEN 15MG TABLET / ORAL AB 2024-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209102-001 BACLOFEN 5MG TABLET / ORAL AB RS 2017-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209102-002 BACLOFEN 10MG TABLET / ORAL AB 2017-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209102-003 BACLOFEN 20MG TABLET / ORAL AB 2017-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209102-004 BACLOFEN 15MG TABLET / ORAL AB 2024-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209102-001 BACLOFEN 5MG TABLET / ORAL AB RS 2017-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209102-002 BACLOFEN 10MG TABLET / ORAL AB 2017-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209102-003 BACLOFEN 20MG TABLET / ORAL AB 2017-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209102-004 BACLOFEN 15MG TABLET / ORAL AB 2024-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209102-001 BACLOFEN 5MG TABLET / ORAL AB RS 2017-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209102-002 BACLOFEN 10MG TABLET / ORAL AB 2017-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209102-003 BACLOFEN 20MG TABLET / ORAL AB 2017-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209102-004 BACLOFEN 15MG TABLET / ORAL AB 2024-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209102-001 BACLOFEN 5MG TABLET / ORAL AB RS 2017-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209102-002 BACLOFEN 10MG TABLET / ORAL AB 2017-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209102-003 BACLOFEN 20MG TABLET / ORAL AB 2017-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209102-004 BACLOFEN 15MG TABLET / ORAL AB 2024-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209102-001 BACLOFEN 5MG TABLET / ORAL AB RS 2017-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209102-002 BACLOFEN 10MG TABLET / ORAL AB 2017-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209102-003 BACLOFEN 20MG TABLET / ORAL AB 2017-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209102-004 BACLOFEN 15MG TABLET / ORAL AB 2024-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209102-001 BACLOFEN 5MG TABLET / ORAL AB RS 2017-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209102-002 BACLOFEN 10MG TABLET / ORAL AB 2017-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209102-003 BACLOFEN 20MG TABLET / ORAL AB 2017-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209102-004 BACLOFEN 15MG TABLET / ORAL AB 2024-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209102-001 BACLOFEN 5MG TABLET / ORAL AB RS 2017-11-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209102-002 BACLOFEN 10MG TABLET / ORAL AB 2017-11-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209102-003 BACLOFEN 20MG TABLET / ORAL AB 2017-11-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209102-004 BACLOFEN 15MG TABLET / ORAL AB 2024-02-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 143 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197391 Internal RxNorm lookup 197392 Internal RxNorm lookup 430902 Internal RxNorm lookup 2679605 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-357 BACLOFEN TABLET [ASCLEMED USA, INC.] 1 Current NDC, 7 package rows 20250524_35bccefe-8d2e-85b5-e063-6394a90a58ca.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 2 of 2 · 24 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 76420-357-01 76420035701 100 TABLET in 1 BOTTLE (76420-357-01) 100 tablet 2025-05-22 No No Current