NDC 71863-114

Carglumic Acid

Carglumic Acid

Carglumic Acid is a Oral Tablet, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Eton Pharmaceuticals, Inc.. The primary component is Carglumic Acid.

Product ID71863-114_6eac88bb-c05f-4010-ba8c-f680de5224ab
NDC71863-114
Product TypeHuman Prescription Drug
Proprietary NameCarglumic Acid
Generic NameCarglumic Acid
Dosage FormTablet, For Suspension
Route of AdministrationORAL
Marketing Start Date2021-12-20
Marketing CategoryANDA /
Application NumberANDA213729
Labeler NameEton Pharmaceuticals, Inc.
Substance NameCARGLUMIC ACID
Active Ingredient Strength200 mg/1
Pharm ClassesCarbamoyl Phosphate Synthetase 1 Activator [EPC],Carbamoyl Phosphate Synthetase 1 Activators [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71863-114-60

1 BOTTLE in 1 CARTON (71863-114-60) > 60 TABLET, FOR SUSPENSION in 1 BOTTLE
Marketing Start Date2021-12-20
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Carglumic Acid" or generic name "Carglumic Acid"

NDCBrand NameGeneric Name
35573-459Carglumic acidCarglumic acid
68475-006Carglumic acidCarglumic acid
70954-120Carglumic AcidCarglumic Acid
71863-114Carglumic AcidCarglumic Acid
52276-312CarbagluCarglumic Acid

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