NDC 68475-006

Carglumic acid

Carglumic Acid

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

Product ID68475-006_99df9818-313d-42a4-a5c3-bfa1d3b6f638
Product TypeHuman Prescription Drug
Proprietary NameCarglumic acid
Generic NameCarglumic Acid
Dosage FormTablet, For Suspension
Route of AdministrationORAL
Marketing Start Date2022-08-01
Marketing CategoryANDA /
Application NumberANDA213395
Labeler NameNavinta LLC
Active Ingredient Strength200 mg/1
Pharm ClassesCarbamoyl Phosphate Synthetase 1 Activator [EPC], Carbamoyl Phosphate Synthetase 1 Activators [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31


NDC 68475-006-01

5 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-01)
Marketing Start Date2022-08-01
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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

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