Home NDC 72888-466-02 Baclofen
Product NDC 72888-466
Requested package NDC 72888-466-02
11-digit product format 728880466
Labeler code 72888
Product ID 72888-466_374c7fbe-ca7e-09b4-e063-6394a90ab5fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form SOLUTION
Route ORAL
Labeler Advagen Pharma Ltd.,
Application ANDA214445
Marketing category ANDA
Marketing start 2025-06-03
Substance BACLOFEN
Active strength 10 mg/5mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214445-001 BACLOFEN BACLOFEN 5MG/5ML SOLUTION / ORAL 2024-12-06 A214445-002 BACLOFEN BACLOFEN 10MG/5ML SOLUTION / ORAL AA 2025-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214445-002 AA
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.
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 A214445-001 BACLOFEN 5MG/5ML SOLUTION / ORAL 2024-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214445-002 BACLOFEN 10MG/5ML SOLUTION / ORAL AA 2025-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214445-001 BACLOFEN 5MG/5ML SOLUTION / ORAL 2024-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214445-002 BACLOFEN 10MG/5ML SOLUTION / ORAL AA 2025-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214445-001 BACLOFEN 5MG/5ML SOLUTION / ORAL 2024-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214445-002 BACLOFEN 10MG/5ML SOLUTION / ORAL AA 2025-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214445-001 BACLOFEN 5MG/5ML SOLUTION / ORAL 2024-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214445-002 BACLOFEN 10MG/5ML SOLUTION / ORAL AA 2025-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214445-001 BACLOFEN 5MG/5ML SOLUTION / ORAL 2024-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214445-002 BACLOFEN 10MG/5ML SOLUTION / ORAL AA 2025-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214445-001 BACLOFEN 5MG/5ML SOLUTION / ORAL 2024-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214445-001 BACLOFEN 5MG/5ML SOLUTION / ORAL 2024-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214445-001 BACLOFEN 5MG/5ML SOLUTION / ORAL 2024-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214445-001 BACLOFEN 5MG/5ML SOLUTION / ORAL 2024-12-06 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214445-001 BACLOFEN 5MG/5ML SOLUTION / ORAL 2024-12-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214445-002 BACLOFEN 10MG/5ML SOLUTION / ORAL AA 2025-06-03 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214445-001 PC 2025-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214445-001 PC 2025-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214445-001 PC 2025-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214445-001 PC 2025-07-14 b8a1b40f171c…
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/5mL
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 2667941 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 72888-466-01 Baclofen 473 mL in 1 BOTTLE SOLUTION 473 1 72888-466-02 Baclofen 237 mL in 1 BOTTLE SOLUTION 237 1
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 · 3 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 72888-466-02 72888046602 237 mL in 1 BOTTLE (72888-466-02) 237 ml 2025-06-03 No No Current