carbidopa and levodopa

Generic: carbidopa and levodopa

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbidopa and levodopa
Generic Name carbidopa and levodopa
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

carbidopa 25 mg/1, levodopa 100 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-187
Product ID 47335-187_5c297458-6e97-4222-8a82-1b28928ce796
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078690
Listing Expiration 2026-12-31
Marketing Start 2014-12-15

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 47335187
Hyphenated Format 47335-187

Supplemental Identifiers

RxCUI
476399 476515 483090
UNII
46627O600J MNX7R8C5VO
NUI
N0000193220 M0370111 N0000175754 N0000175755

Packaging Origin

Original Packager
true

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 ANDA078690 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-08)
  • 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-18)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-83)
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-88)
source: ndc

Packages (4)

47335-187-08 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-08) 47335-187-18 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-18) 47335-187-83 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-83) 47335-187-88 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-88)

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": "5c297458-6e97-4222-8a82-1b28928ce796", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["476399", "476515", "483090"], "spl_set_id": ["48e0f2ec-b217-4c25-a71c-20e173d05edb"], "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": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-08)", "package_ndc": "47335-187-08", "marketing_start_date": "20141215"}, {"sample": false, "description": "1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-18)", "package_ndc": "47335-187-18", "marketing_start_date": "20141215"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-83)", "package_ndc": "47335-187-83", "marketing_start_date": "20141215"}, {"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-187-88)", "package_ndc": "47335-187-88", "marketing_start_date": "20141215"}], "brand_name": "CARBIDOPA AND LEVODOPA", "product_id": "47335-187_5c297458-6e97-4222-8a82-1b28928ce796", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "47335-187", "generic_name": "CARBIDOPA AND LEVODOPA", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "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": "ANDA078690", "marketing_category": "ANDA", "marketing_start_date": "20141215", "listing_expiration_date": "20261231"}