carbidopa and levodopa (46708-333)

Drug Facts

Product Profile

Brand Name carbidopa and levodopa

Generic Name carbidopa and levodopa

Labeler alembic pharmaceuticals limited

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

carbidopa 50 mg/1, levodopa 200 mg/1

Manufacturer

Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-333

Product ID 46708-333_a85a56c5-44dd-41d4-ac1c-bdc4758406a4

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA210341

Listing Expiration 2026-12-31

Marketing Start 2019-06-06

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 46708333

Hyphenated Format 46708-333

Supplemental Identifiers

RxCUI

308988 308989

UPC

0346708332303 0346708333300

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 ANDA210341 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

50 mg/1
200 mg/1

source: ndc

Packaging

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-30)
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-31)
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-91)

source: ndc

Packages (3)

46708-333-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-30) 46708-333-31 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-31) 46708-333-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-91)

Ingredients (2)

carbidopa (50 mg/1) levodopa (200 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": "a85a56c5-44dd-41d4-ac1c-bdc4758406a4", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "upc": ["0346708332303", "0346708333300"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["308988", "308989"], "spl_set_id": ["a85a56c5-44dd-41d4-ac1c-bdc4758406a4"], "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": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-30)", "package_ndc": "46708-333-30", "marketing_start_date": "20190606"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-31)", "package_ndc": "46708-333-31", "marketing_start_date": "20190606"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-91)", "package_ndc": "46708-333-91", "marketing_start_date": "20190606"}], "brand_name": "Carbidopa and Levodopa", "product_id": "46708-333_a85a56c5-44dd-41d4-ac1c-bdc4758406a4", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "46708-333", "generic_name": "Carbidopa and Levodopa", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa and Levodopa", "active_ingredients": [{"name": "CARBIDOPA", "strength": "50 mg/1"}, {"name": "LEVODOPA", "strength": "200 mg/1"}], "application_number": "ANDA210341", "marketing_category": "ANDA", "marketing_start_date": "20190606", "listing_expiration_date": "20261231"}