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FDA Approval

Carbidopa and levodopa

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 12, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Carbidopa(25 mg in 1 1)
Levodopa(100 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Carbidopa and levodopa

Product Details

NDC Product Code
50090-3419
Application Number
ANDA074260
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 30, 2020
CarbidopaActive
Code: MNX7R8C5VOClass: ACTIMQuantity: 25 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
LevodopaActive
Code: 46627O600JClass: ACTIBQuantity: 100 mg in 1 1
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