Carglumic Acid

Product NDC: 70954-120
11-digit product format: 709540120
Labeler code: 70954
Product ID: 70954-120_5c392737-44e7-45f1-bfc1-ec0cc017cdc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carglumic Acid
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Novitium Pharma LLC
Application: ANDA213729
Marketing category: ANDA
Marketing start: 2021-10-13
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

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
A213729-001	CARGLUMIC ACID	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB		2021-10-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A213729-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213729-001	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	2021-10-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213729-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213729-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213729-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213729-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213729-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213729-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213729-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213729-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213729-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213729-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213729-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213729-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213729-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213729-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213729-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213729-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213729-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213729-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213729-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213729-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213729-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213729-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213729-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213729-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213729-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213729-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213729-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213729-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213729-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213729-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213729-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213729-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213729-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213729-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213729-001	CGT	2022-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213729-001	CGT	2022-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213729-001	CGT	2022-06-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213729-001	CGT	2022-06-18	`bb7c543d1eb4…`
2023-01-26 05:58 UTC	2023-01	A213729-001	CGT	2022-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213729-001	CGT	2022-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213729-001	CGT	2022-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213729-001	CGT	2022-06-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213729-001	CGT	2022-06-18	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carglumic Acid	CARGLUMIC ACID	Eton Pharmaceuticals, Inc.	591f95ca-3d99-4fb6-a402-e5a383a746d0	2026-03-03	Adverse reactions	Exact identifier application applno (ANDA): 213729 application number: ANDA213729

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5L0HB4V1EW	CARGLUMIC ACID	1188-38-1	CARGLUMIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70954-120-10	70954012010	1 BOTTLE in 1 CARTON (70954-120-10) > 60 TABLET, FOR SUSPENSION in 1 BOTTLE	1 bottle	2021-10-13	0000-00-00	No	No	Current