Home NDC 80425-0282 Baclofen
Product NDC 80425-0282
11-digit product format 804250282
Labeler code 80425
Product ID 80425-0282_26f8bbf8-7c53-4c19-e063-6394a90a5a4a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form TABLET
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA212378
Marketing category ANDA
Marketing start 2020-10-09
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 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 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 80425-0282-1 Baclofen 30 in 1 BOTTLE TABLET 30 2 80425-0282-2 Baclofen 60 in 1 BOTTLE TABLET 60 2 80425-0282-3 Baclofen 90 in 1 BOTTLE TABLET 90 2 80425-0282-4 Baclofen 120 in 1 BOTTLE TABLET 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0282 BACLOFEN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 2 Current NDC, 4 package rows 20241116_f5edb656-4f7e-2386-e053-2995a90a70de.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 80425-0282-1 80425028201 30 TABLET in 1 BOTTLE (80425-0282-1) 30 tablet 2020-10-09 No No Current 80425-0282-2 80425028202 60 TABLET in 1 BOTTLE (80425-0282-2) 60 tablet 2020-10-09 No No Current 80425-0282-3 80425028203 90 TABLET in 1 BOTTLE (80425-0282-3) 90 tablet 2020-10-09 No No Current 80425-0282-4 80425028204 120 TABLET in 1 BOTTLE (80425-0282-4) 120 tablet 2024-11-15 No No Current