FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Carbaglu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARGLUMIC ACID200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5L0HB4V1EW
Rxcui905390, 905394

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9860662a-dd40-3c34-05c2-84feaf18f015Product name320230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52276-312-05Carbaglu5 in 1 BOTTLETABLET, FOR SUSPENSION536
52276-312-60Carbaglu60 in 1 BOTTLETABLET, FOR SUSPENSION6036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52276-312-05EA - Each52276-312d121c381-76aa-4901-be3b-bda43e5b4fa212012-07-24
52276-312-60EA - Each52276-312bd6ec255-2823-4645-949c-f7ebfd2b458d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Carglumic acidACTIVE INGREDIENT5L0HB4V1EWCARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]20
Carglumic acidACTIVE MOIETY5L0HB4V1EWCARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]20
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UCARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]20
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]20
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]20
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]20
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JCARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]20
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UICARBAGLU (CARGLUMIC ACID) TABLET [ORPHAN EUROPE, SARL]20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52276-312CARBAGLU (CARGLUMIC ACID) TABLET, FOR SUSPENSION [RECORDATI RARE DISEASES]36Current NDC, Legacy NDC, 2 package rows20240131_10175e73-5172-4dde-a508-8a88b7afc0a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905394Carbaglu 200 MG Tablet for Oral SuspensionPSN10175e73-5172-4dde-a508-8a88b7afc0a136
905390carglumic acid 200 MG Tablet for Oral SuspensionPSN10175e73-5172-4dde-a508-8a88b7afc0a136
905394carglumic acid 200 MG Tablet for Oral Suspension [Carbaglu]SBD10175e73-5172-4dde-a508-8a88b7afc0a136
905390carglumic acid 200 MG Tablet for Oral SuspensionSCD10175e73-5172-4dde-a508-8a88b7afc0a136
905394Carbaglu 200 MG Dispersible Tablet for Oral SuspensionSY10175e73-5172-4dde-a508-8a88b7afc0a136
905390carglumic acid 200 MG Dispersible Tablet for Oral SuspensionSY10175e73-5172-4dde-a508-8a88b7afc0a136

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52276-312-05522760312055 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-05) 2010-03-180000-00-00NoNoCurrent
52276-312-605227603126060 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-60) 2010-03-180000-00-00NoNoCurrent