Home NDC 25021-680 Baclofen
Product NDC 25021-680
11-digit product format 250210680
Labeler code 25021
Product ID 25021-680_81266703-bafa-4e31-a400-32fbfe1a849e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Baclofen
Dosage form INJECTION, SOLUTION
Route INTRATHECAL
Labeler Sagent Pharmaceuticals
Application ANDA210315
Marketing category ANDA
Marketing start 2021-07-15
Substance BACLOFEN
Active strength 1000 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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210315-001 BACLOFEN BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210315-001 AP
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 2026-02-19 14:30 UTC 2026-02 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210315-001 BACLOFEN 1MG/ML INJECTABLE / INTRATHECAL AP 2019-07-30 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Baclofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACLOFEN 1000 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1300890 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 25021-680-20 Baclofen 1 in 1 CARTON INJECTION, SOLUTION 1 2 25021-680-20 Baclofen 20 mL in 1 VIAL INJECTION, SOLUTION 20 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-680 BACLOFEN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 Current NDC, Legacy NDC, 2 package rows 20250515_d4bfba33-9f4d-4c43-ae6c-bcf67ef8fe51.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 Units Marketing start Marketing end Sample Exclude flag Status 25021-680-20 25021068020 1 VIAL in 1 CARTON (25021-680-20) / 20 mL in 1 VIAL 1 vial 2021-07-15 0000-00-00 No No Current