carbidopa-levodopa

Generic: carbidopa and levodopa

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbidopa-levodopa
Generic Name carbidopa and levodopa
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbidopa 10 mg/1, levodopa 100 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68002-100
Product ID 68002-100_3a9d54e8-0ed9-4e71-e063-6394a90ac4ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216505
Listing Expiration 2026-12-31
Marketing Start 2025-07-28

Pharmacologic Class

Established (EPC)
aromatic amino acid decarboxylation inhibitor [epc] aromatic amino acid [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 68002100
Hyphenated Format 68002-100

Supplemental Identifiers

RxCUI
197443
UNII
MNX7R8C5VO 46627O600J
NUI
N0000175754 N0000175755 N0000193220 M0370111

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-levodopa (source: ndc)
Generic Name carbidopa and levodopa (source: ndc)
Application Number ANDA216505 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (68002-100-04) / 1 TABLET in 1 BLISTER PACK (68002-100-02)
source: ndc

Packages (1)

Ingredients (2)

carbidopa (10 mg/1) levodopa (100 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3a9d54e8-0ed9-4e71-e063-6394a90ac4ff", "openfda": {"nui": ["N0000175754", "N0000175755", "N0000193220", "M0370111"], "unii": ["MNX7R8C5VO", "46627O600J"], "rxcui": ["197443"], "spl_set_id": ["dd2215a9-ee0f-443a-a2e3-3d0578c8cd8f"], "pharm_class_cs": ["Amino Acids, Aromatic [CS]"], "pharm_class_epc": ["Aromatic Amino Acid Decarboxylation Inhibitor [EPC]", "Aromatic Amino Acid [EPC]"], "pharm_class_moa": ["DOPA Decarboxylase Inhibitors [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (68002-100-04)  / 1 TABLET in 1 BLISTER PACK (68002-100-02)", "package_ndc": "68002-100-04", "marketing_start_date": "20250728"}], "brand_name": "Carbidopa-levodopa", "product_id": "68002-100_3a9d54e8-0ed9-4e71-e063-6394a90ac4ff", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "68002-100", "generic_name": "carbidopa and levodopa", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa-levodopa", "active_ingredients": [{"name": "CARBIDOPA", "strength": "10 mg/1"}, {"name": "LEVODOPA", "strength": "100 mg/1"}], "application_number": "ANDA216505", "marketing_category": "ANDA", "marketing_start_date": "20250728", "listing_expiration_date": "20261231"}