CARBIDOPA AND LEVODOPA

Product NDC
68001-171
11-digit product format
680010171
Labeler code
68001
Product ID
68001-171_9d0cb864-53d9-4151-b557-dd5114903d6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA202323
Marketing category
ANDA
Marketing start
2014-01-22
Marketing end
0000-00-00
Substance
CARBIDOPA; LEVODOPA
Active strength
25 mg/1; mg/1
Pharmacologic classes
Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-171-00EA - Each68001-171b30ab94e-afe1-4710-926f-5097906bf5a112014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-171CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]7Legacy NDC20250322_58a6e76a-f99f-4f0c-9d83-a55a30edda97.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-171-0068001017100100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-171-00) 2014-01-220000-00-00NoNoCurrent