Home NDC 72162-2372 Baclofen
Product NDC 72162-2372
11-digit product format 721622372
Labeler code 72162
Product ID 72162-2372_591d3710-acae-41ca-b8e2-5904e2ea8089
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA212378
Marketing category ANDA
Marketing start 2024-06-15
Substance BACLOFEN
Active strength 5 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212378-001 BACLOFEN BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 A212378-002 BACLOFEN BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 A212378-003 BACLOFEN BACLOFEN 5MG TABLET / ORAL AB 2021-04-30
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 3 · 111 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 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212378-002 BACLOFEN 20MG TABLET / ORAL AB 2020-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212378-003 BACLOFEN 5MG TABLET / ORAL AB 2021-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212378-001 BACLOFEN 10MG TABLET / ORAL AB 2020-10-09 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 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 5 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 430902 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 72162-2372-1 Baclofen 100 in 1 BOTTLE TABLET 100 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2372 BACLOFEN TABLET [BRYANT RANCH PREPACK] 101 Current NDC, 1 package rows 20241128_43cafbdb-6927-45f6-9b16-3b125cc2a29d.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 · 23 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 72162-2372-1 72162237201 100 TABLET in 1 BOTTLE (72162-2372-1) 100 tablet 2024-07-18 No No Current