Carglumic Acid

Product NDC: 71863-114
11-digit product format: 718630114
Labeler code: 71863
Product ID: 71863-114_ce6d0fd4-bbe0-4a22-bfb5-33326b63a67f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carglumic Acid
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Eton Pharmaceuticals, Inc.
Application: ANDA213729
Marketing category: ANDA
Marketing start: 2021-12-20
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: 2027-12-31
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carglumic Acid
Listing expiration: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
591f95ca-3d99-4fb6-a402-e5a383a746d0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9860662a-dd40-3c34-05c2-84feaf18f015	Product name	3	20230314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71863-114-60	2026-01-29	C162847	48780-1	1030e364-fde1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION. CARGLUMIC ACID tablets for oral suspension Initial U.S. Approval: 2010
71863-114-60	2024-02-09	C162847	48780-1	1030e364-fde1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION. CARGLUMIC ACID tablets for oral suspension Initial U.S. Approval: 2010
71863-114-60	2024-01-30	C162847	48780-1	1030e364-fde1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION. CARGLUMIC ACID tablets for oral suspension Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71863-114-60	Carglumic Acid	60 in 1 BOTTLE	TABLET, FOR SUSPENSION	60		4
71863-114-60	Carglumic Acid	1 in 1 CARTON	TABLET, FOR SUSPENSION	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71863-114-60	EA - Each	71863-114	68e61972-5b1d-40d5-8957-ce9b39add125	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71863-114	CARGLUMIC ACID TABLET, FOR SUSPENSION [ETON PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20240210_591f95ca-3d99-4fb6-a402-e5a383a746d0.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 · 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 ndc (product): 71863-114

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
905390	carglumic acid 200 MG Tablet for Oral Suspension	PSN	591f95ca-3d99-4fb6-a402-e5a383a746d0	4
905390	carglumic acid 200 MG Tablet for Oral Suspension	SCD	591f95ca-3d99-4fb6-a402-e5a383a746d0	4
905390	carglumic acid 200 MG Dispersible Tablet for Oral Suspension	SY	591f95ca-3d99-4fb6-a402-e5a383a746d0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71863-114-60	71863011460	1 BOTTLE in 1 CARTON (71863-114-60) / 60 TABLET, FOR SUSPENSION in 1 BOTTLE	1 bottle	2021-12-20	0000-00-00	No	No	Current