Home NDC 35573-459 Carglumic acid
Product NDC 35573-459
11-digit product format 355730459
Labeler code 35573
Product ID 35573-459_28393de7-fa10-4e7d-919e-4d0b19c888a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carglumic acid
Dosage form TABLET, FOR SUSPENSION
Route ORAL
Labeler Burel Pharmaceuticals, LLC
Application ANDA213395
Marketing category ANDA
Marketing start 2022-12-19
Substance CARGLUMIC ACID
Active strength 200 mg/1
Pharmacologic classes Carbamoyl Phosphate Synthetase 1 Activator [EPC], Carbamoyl Phosphate Synthetase 1 Activators [MoA]
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 42 .
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 A213395-001 CARGLUMIC ACID CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213395-001 AB
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 2026-08-18 06:07:40 2026-07 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213395-001 CARGLUMIC ACID 200MG TABLET, FOR SUSPENSION / ORAL AB 2022-06-22 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Carglumic acid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARGLUMIC ACID 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5L0HB4V1EW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905390 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 35573-459-60 Carglumic acid 60 in 1 BOTTLE TABLET, FOR SUSPENSION 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35573-459 CARGLUMIC ACID TABLET, FOR SUSPENSION [BUREL PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20240329_2aee4281-402b-4cd6-9e6a-08945262e1a1.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 Marketing end Sample Exclude flag Status 35573-459-60 35573045960 60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60) 2022-12-19 0000-00-00 No No Current