Home NDC 72888-145-36 BACLOFEN
Product NDC 72888-145
Requested package NDC 72888-145-36
11-digit product format 728880145
Labeler code 72888
Product ID 72888-145_45801dc3-fb9b-c31e-e063-6294a90aff35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form INJECTION
Route INTRATHECAL
Labeler Advagen Pharma Limited
Application ANDA217324
Marketing category ANDA
Marketing start 2023-02-22
Substance BACLOFEN
Active strength 500 ug/mL
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 A217324-001 BACLOFEN BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 A217324-002 BACLOFEN BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 A217324-003 BACLOFEN BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22
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 2 · 75 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 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217324-002 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217324-003 BACLOFEN 2MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217324-001 BACLOFEN 0.5MG/ML INJECTABLE / INTRATHECAL AP 2023-02-22 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 75 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 500 ug/mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308517 Internal RxNorm lookup 1300890 Internal RxNorm lookup 1666613 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 72888-145-36 BACLOFEN 1 in 1 CARTON INJECTION 1 6 72888-145-36 BACLOFEN 20 mL in 1 VIAL, GLASS INJECTION 20 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72888-145 BACLOFEN INJECTION [ADVAGEN PHARMA LIMITED] 1 Current NDC, 2 package rows 20230307_d63af5f0-c275-480b-89b5-6cf1ad55ab63.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 Marketing start Sample Exclude flag Status 72888-145-36 72888014536 1 VIAL, GLASS in 1 CARTON (72888-145-36) / 20 mL in 1 VIAL, GLASS 2023-02-22 No No Current