NDC 70954-120

Carglumic Acid

Carglumic Acid

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

Product ID70954-120_5c392737-44e7-45f1-bfc1-ec0cc017cdc8
NDC70954-120
Product TypeHuman Prescription Drug
Proprietary NameCarglumic Acid
Generic NameCarglumic Acid
Dosage FormTablet, For Suspension
Route of AdministrationORAL
Marketing Start Date2021-10-13
Marketing CategoryANDA /
Application NumberANDA213729
Labeler NameNovitium Pharma LLC
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 70954-120-10

1 BOTTLE in 1 CARTON (70954-120-10) > 60 TABLET, FOR SUSPENSION in 1 BOTTLE
Marketing Start Date2021-10-13
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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