FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARGLUMIC ACID200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5L0HB4V1EW
Rxcui905390

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71863-114-602026-01-29C16284748780-11030e364-fde1-111a-e063-dadaa90a10e2These 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
71863-114-602024-02-09C16284748780-11030e364-fde1-111a-e063-dadaa90a10e2These 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
71863-114-602024-01-30C16284748780-11030e364-fde1-111a-e063-dadaa90a10e2These 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 NDCProductDescriptionFormQuantityStrengthSPL version
71863-114-60Carglumic Acid60 in 1 BOTTLETABLET, FOR SUSPENSION604
71863-114-60Carglumic Acid1 in 1 CARTONTABLET, FOR SUSPENSION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71863-114-60EA - Each71863-11468e61972-5b1d-40d5-8957-ce9b39add12512022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71863-114CARGLUMIC ACID TABLET, FOR SUSPENSION [ETON PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20240210_591f95ca-3d99-4fb6-a402-e5a383a746d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905390carglumic acid 200 MG Tablet for Oral SuspensionPSN591f95ca-3d99-4fb6-a402-e5a383a746d04
905390carglumic acid 200 MG Tablet for Oral SuspensionSCD591f95ca-3d99-4fb6-a402-e5a383a746d04
905390carglumic acid 200 MG Dispersible Tablet for Oral SuspensionSY591f95ca-3d99-4fb6-a402-e5a383a746d04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71863-114-60718630114601 BOTTLE in 1 CARTON (71863-114-60) / 60 TABLET, FOR SUSPENSION in 1 BOTTLE1 bottle2021-12-200000-00-00NoNoCurrent