carbidopa and levodopa

Generic: carbidopa and levodopa

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbidopa and levodopa
Generic Name carbidopa and levodopa
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbidopa 25 mg/1, levodopa 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7501
Product ID 0904-7501_f5d5ad01-a099-46cd-95fc-98ebc80ddc96
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073589
Listing Expiration 2026-12-31
Marketing Start 2024-07-02

Pharmacologic Class

Established (EPC)
aromatic amino acid [epc] aromatic amino acid decarboxylation inhibitor [epc]
Mechanism of Action
dopa decarboxylase inhibitors [moa]
Chemical Structure
amino acids, aromatic [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047501
Hyphenated Format 0904-7501

Supplemental Identifiers

RxCUI
197444 197445
UNII
46627O600J MNX7R8C5VO
NUI
N0000193220 M0370111 N0000175754 N0000175755

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name carbidopa and levodopa (source: ndc)
Generic Name carbidopa and levodopa (source: ndc)
Application Number ANDA073589 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7501-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7501-61 100 BLISTER PACK in 1 CARTON (0904-7501-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (2)

carbidopa (25 mg/1) levodopa (100 mg/1)

Linked Drug Pages (1)

Carbidopa and Levodopa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f5d5ad01-a099-46cd-95fc-98ebc80ddc96", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["197444", "197445"], "spl_set_id": ["3f6d393e-ac84-4a3c-a837-199d1ec71fd2"], "pharm_class_cs": ["Amino Acids, Aromatic [CS]"], "pharm_class_epc": ["Aromatic Amino Acid [EPC]", "Aromatic Amino Acid Decarboxylation Inhibitor [EPC]"], "pharm_class_moa": ["DOPA Decarboxylase Inhibitors [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7501-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7501-61", "marketing_start_date": "20240702"}], "brand_name": "Carbidopa and Levodopa", "product_id": "0904-7501_f5d5ad01-a099-46cd-95fc-98ebc80ddc96", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "0904-7501", "generic_name": "Carbidopa and Levodopa", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa and Levodopa", "active_ingredients": [{"name": "CARBIDOPA", "strength": "25 mg/1"}, {"name": "LEVODOPA", "strength": "100 mg/1"}], "application_number": "ANDA073589", "marketing_category": "ANDA", "marketing_start_date": "20240702", "listing_expiration_date": "20261231"}