Home NDC 52536-600 Baclofen
Product NDC 52536-600
11-digit product format 525360600
Labeler code 52536
Product ID 52536-600_461e14b2-890c-011c-e063-6294a90a0d4c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name baclofen
Dosage form SUSPENSION
Route ORAL
Labeler Wilshire Pharmaceuticals, Inc.
Application NDA215602
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2023-04-01
Substance BACLOFEN
Active strength 5 mg/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 N215602-001 FLEQSUVY BACLOFEN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N215602-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215602-001 11446246 2037-09-08 U-3433 2022-09-30 N215602-001 11324696 2037-09-29 Drug product 2022-05-16
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 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL RLD, RS 2022-02-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL RLD, RS 2022-02-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL RLD, RS 2022-02-04 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL RLD, RS 2022-02-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL RLD, RS 2022-02-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL RLD, RS 2022-02-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL RLD, RS 2022-02-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL RLD, RS 2022-02-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL RLD, RS 2022-02-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL RLD, RS 2022-02-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215602-001 FLEQSUVY 25MG/5ML SUSPENSION / ORAL AB RLD, RS 2022-02-04 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 55 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215602-001 11324696 2037-09-29 Drug product 2022-05-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215602-001 11446246 2037-09-08 U-3433 2022-09-30 a67488948f0b…
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/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 2593376 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 52536-600-11 Baclofen 1 in 1 CARTON SUSPENSION 1 3 52536-600-11 Baclofen 120 mL in 1 BOTTLE SUSPENSION 120 3 52536-600-12 Baclofen 300 mL in 1 BOTTLE SUSPENSION 300 3 52536-600-12 Baclofen 1 in 1 CARTON SUSPENSION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52536-600 BACLOFEN SUSPENSION [WILSHIRE PHARMACEUTICALS, INC.] 2 Current NDC, 4 package rows 20240518_4585aafe-0af8-4786-a419-6a7e76671ca2.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 Sample Exclude flag Status 52536-600-11 52536060011 1 BOTTLE in 1 CARTON (52536-600-11) / 120 mL in 1 BOTTLE 1 bottle 2023-04-01 No No Current 52536-600-12 52536060012 1 BOTTLE in 1 CARTON (52536-600-12) / 300 mL in 1 BOTTLE 1 bottle 2023-04-01 No No Current