carbidopa-levodopa

Generic: carbidopa and levodopa

Labeler: advagen pharma ltd.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbidopa-levodopa
Generic Name carbidopa and levodopa
Labeler advagen pharma ltd.,
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbidopa 10 mg/1, levodopa 100 mg/1

Manufacturer
Advagen Pharma Ltd.,

Identifiers & Regulatory

Product NDC 72888-106
Product ID 72888-106_473c9b78-59d1-689d-e063-6294a90a2f0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216505
Listing Expiration 2026-12-31
Marketing Start 2022-09-21

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 72888106
Hyphenated Format 72888-106

Supplemental Identifiers

RxCUI
197443 197444 197445
UPC
0372888108056 0372888108308 0372888107301 0372888107059 0372888106014 0372888108018 0372888107004 0372888106007 0372888106052 0372888106304 0372888108001 0372888107011
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-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
  • 1000 TABLET in 1 BOTTLE (72888-106-00)
  • 100 TABLET in 1 BOTTLE (72888-106-01)
  • 500 TABLET in 1 BOTTLE (72888-106-05)
  • 30 TABLET in 1 BOTTLE (72888-106-30)
source: ndc

Packages (4)

72888-106-00 1000 TABLET in 1 BOTTLE (72888-106-00) 72888-106-01 100 TABLET in 1 BOTTLE (72888-106-01) 72888-106-05 500 TABLET in 1 BOTTLE (72888-106-05) 72888-106-30 30 TABLET in 1 BOTTLE (72888-106-30)

Ingredients (2)

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

Linked Drug Pages (1)

Carbidopa-levodopa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "473c9b78-59d1-689d-e063-6294a90a2f0a", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "upc": ["0372888108056", "0372888108308", "0372888107301", "0372888107059", "0372888106014", "0372888108018", "0372888107004", "0372888106007", "0372888106052", "0372888106304", "0372888108001", "0372888107011"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["197443", "197444", "197445"], "spl_set_id": ["9e3c796b-2e68-4bcc-b927-18a58bea4703"], "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": ["Advagen Pharma Ltd.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (72888-106-00)", "package_ndc": "72888-106-00", "marketing_start_date": "20230201"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (72888-106-01)", "package_ndc": "72888-106-01", "marketing_start_date": "20230201"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72888-106-05)", "package_ndc": "72888-106-05", "marketing_start_date": "20230201"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72888-106-30)", "package_ndc": "72888-106-30", "marketing_start_date": "20230201"}], "brand_name": "Carbidopa-levodopa", "product_id": "72888-106_473c9b78-59d1-689d-e063-6294a90a2f0a", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "72888-106", "generic_name": "carbidopa and levodopa", "labeler_name": "Advagen Pharma Ltd.,", "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": "20220921", "listing_expiration_date": "20261231"}