Carbidopa and Levodopa

Product NDC
71610-647
11-digit product format
716100647
Labeler code
71610
Product ID
71610-647_188d3827-60b2-4893-a8db-21433377eb1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA214092
Marketing category
ANDA
Marketing start
2021-05-07
Substance
CARBIDOPA; LEVODOPA
Active strength
25; 100 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
MNX7R8C5VOCARBIDOPA38821-49-7CARBIDOPA
46627O600JLEVODOPA59-92-7LEVODOPA

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-647-607161006476090 TABLET in 1 BOTTLE (71610-647-60) 90 tablet2022-05-02NoNoHistorical
71610-647-8071610064780180 TABLET in 1 BOTTLE (71610-647-80) 180 tablet2022-05-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Carbidopa and Levodopa Tablets, USP Rx onlyAphena Pharma Solutions - Tennessee, LLC2022-05-11HUMAN PRESCRIPTION DRUG LABEL3