Carbaglu

Product NDC: 52276-312
11-digit product format: 522760312
Labeler code: 52276
Product ID: 52276-312_7238020c-dcef-42ca-947b-6162e1488608
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carglumic Acid
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Recordati Rare Diseases
Application: NDA022562
Marketing category: NDA
Marketing start: 2010-03-18
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
N022562-001	CARBAGLU	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022562-001	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022562-001	ODE-345	2028-01-22

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.

Product history page 1 of 2 · 42 observed 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	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022562-001	CARBAGLU	200MG	TABLET / ORAL		RLD, RS	2010-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2010-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2010-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2010-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2010-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022562-001	CARBAGLU	200MG	TABLET / ORAL		RLD, RS	2010-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022562-001	CARBAGLU	200MG	TABLET / ORAL		RLD, RS	2010-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022562-001	CARBAGLU	200MG	TABLET / ORAL		RLD, RS	2010-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022562-001	CARBAGLU	200MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2010-03-18	`e64feba35796…`

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	N022562-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022562-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022562-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022562-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022562-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022562-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022562-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022562-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022562-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022562-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022562-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022562-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022562-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022562-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022562-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022562-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022562-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022562-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022562-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022562-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022562-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022562-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022562-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022562-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022562-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022562-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022562-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022562-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022562-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022562-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022562-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022562-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022562-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022562-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N022562-001	ODE-345	2028-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022562-001	ODE-345	2028-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022562-001	ODE-345	2028-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022562-001	ODE-345	2028-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022562-001	ODE-345	2028-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022562-001	ODE-345	2028-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022562-001	ODE-345	2028-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022562-001	ODE-345	2028-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022562-001	ODE-345	2028-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022562-001	ODE-345	2028-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022562-001	ODE-345	2028-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022562-001	ODE-345	2028-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022562-001	ODE-345	2028-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022562-001	ODE-345	2028-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022562-001	ODE-345	2028-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022562-001	ODE-345	2028-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022562-001	ODE-345	2028-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022562-001	ODE-345	2028-01-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022562-001	ODE-345	2028-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022562-001	ODE-345	2028-01-22	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022562-001	ODE-345	2028-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022562-001	ODE-345	2028-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022562-001	ODE-345	2028-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022562-001	ODE-345	2028-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022562-001	ODE-345	2028-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022562-001	ODE-345	2028-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022562-001	ODE-345	2028-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022562-001	ODE-345	2028-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022562-001	ODE-345	2028-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022562-001	ODE-345	2028-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022562-001	ODE-345	2028-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022562-001	ODE-345	2028-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022562-001	ODE-345	2028-01-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022562-001	ODE-345	2028-01-22	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carbaglu
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905390	Internal RxNorm lookup
905394	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
10175e73-5172-4dde-a508-8a88b7afc0a1	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52276-312-05	Carbaglu	5 in 1 BOTTLE	TABLET, FOR SUSPENSION	5		36
52276-312-60	Carbaglu	60 in 1 BOTTLE	TABLET, FOR SUSPENSION	60		36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52276-312-05	EA - Each	52276-312	d121c381-76aa-4901-be3b-bda43e5b4fa2	1	2012-07-24
52276-312-60	EA - Each	52276-312	bd6ec255-2823-4645-949c-f7ebfd2b458d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Carglumic acid	ACTIVE INGREDIENT	5L0HB4V1EW	CARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]	20
Carglumic acid	ACTIVE MOIETY	5L0HB4V1EW	CARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]	20
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]	20
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]	20
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]	20
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]	20
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	CARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]	20
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	CARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52276-312	CARBAGLU (CARGLUMIC ACID) TABLET, FOR SUSPENSION [RECORDATI RARE DISEASES]	36	Current NDC, Legacy NDC, 2 package rows	20240131_10175e73-5172-4dde-a508-8a88b7afc0a1.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
Carbaglu	CARGLUMIC ACID	Recordati Rare Diseases	10175e73-5172-4dde-a508-8a88b7afc0a1	2024-01-25	Adverse reactions	Exact identifier application applno (NDA): 022562 application number: NDA022562 ndc (product): 52276-312

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
905394	Carbaglu 200 MG Tablet for Oral Suspension	PSN	10175e73-5172-4dde-a508-8a88b7afc0a1	36
905390	carglumic acid 200 MG Tablet for Oral Suspension	PSN	10175e73-5172-4dde-a508-8a88b7afc0a1	36
905394	carglumic acid 200 MG Tablet for Oral Suspension [Carbaglu]	SBD	10175e73-5172-4dde-a508-8a88b7afc0a1	36
905390	carglumic acid 200 MG Tablet for Oral Suspension	SCD	10175e73-5172-4dde-a508-8a88b7afc0a1	36
905394	Carbaglu 200 MG Dispersible Tablet for Oral Suspension	SY	10175e73-5172-4dde-a508-8a88b7afc0a1	36
905390	carglumic acid 200 MG Dispersible Tablet for Oral Suspension	SY	10175e73-5172-4dde-a508-8a88b7afc0a1	36

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52276-312-05	52276031205	5 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-05)	2010-03-18	0000-00-00	No	No	Current
52276-312-60	52276031260	60 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-60)	2010-03-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbaglu	Recordati Rare Diseases \| Aesica Pharmaceuticals GmbH	2024-01-25	HUMAN PRESCRIPTION DRUG LABEL	36