FDA.reportPublic FDA data

CARBIDOPA AND LEVODOPA

Product NDC
16729-078
11-digit product format
167290078
Labeler code
16729
Product ID
16729-078_40a9fe53-d24b-d4ad-e063-6294a90aeff5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA202323
Marketing category
ANDA
Marketing start
2013-06-13
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

Additional Listing Data#

Finished product
Yes
Brand name base
CARBIDOPA AND LEVODOPA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA25 mg/1
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46627O600J, MNX7R8C5VO
Rxcui308988, 308989

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ce6fab2-d006-4589-8ba0-02cee499cc60Product name220260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442Product name520251106
162160fe-5ea6-4f9d-aa38-c4b780c57046Product name120250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42Product name120250312
028fdaca-77da-0dfe-e445-7dfc440fc97eProduct name420250224
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name720241218
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-078-01CARBIDOPA AND LEVODOPA100 in 1 BOTTLETABLET, EXTENDED RELEASE10011
16729-078-10CARBIDOPA AND LEVODOPA30 in 1 BOTTLETABLET, EXTENDED RELEASE3011
16729-078-16CARBIDOPA AND LEVODOPA500 in 1 BOTTLETABLET, EXTENDED RELEASE50011
16729-078-17CARBIDOPA AND LEVODOPA1000 in 1 BOTTLETABLET, EXTENDED RELEASE100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-078-01EA - Each16729-07885565135-8035-499c-b8c8-bcd53f4ddb9712013-07-02
16729-078-17EA - Each16729-07803ccd1ff-3f11-4abf-95c9-b59e14ab6ac312013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-078CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]10Current NDC, Legacy NDC, 4 package rows20240328_5217a6ec-cc26-4acc-b2da-17f6545c3b60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSN5217a6ec-cc26-4acc-b2da-17f6545c3b6011
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletPSN5217a6ec-cc26-4acc-b2da-17f6545c3b6011
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCD5217a6ec-cc26-4acc-b2da-17f6545c3b6011
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletSCD5217a6ec-cc26-4acc-b2da-17f6545c3b6011
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSY5217a6ec-cc26-4acc-b2da-17f6545c3b6011
308989carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral TabletSY5217a6ec-cc26-4acc-b2da-17f6545c3b6011
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSY5217a6ec-cc26-4acc-b2da-17f6545c3b6011
308989Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral TabletSY5217a6ec-cc26-4acc-b2da-17f6545c3b6011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-078-0116729007801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-01) 2013-06-130000-00-00NoNoCurrent
16729-078-101672900781030 in 1 BOTTLEHistorical
16729-078-1616729007816500 in 1 BOTTLEHistorical
16729-078-17167290078171000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-17) 2013-10-310000-00-00NoNoCurrent