FDA.reportPublic FDA data

CARBIDOPA AND LEVODOPA

Product NDC
62756-518
11-digit product format
627560518
Labeler code
62756
Product ID
62756-518_d77ed25a-588d-4d22-855f-f93ba5b4003c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBIDOPA AND LEVODOPA
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078536
Marketing category
ANDA
Marketing start
2008-10-28
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
Rxcui197443, 197444, 197445

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
62756-518-08CARBIDOPA AND LEVODOPA100 in 1 BOTTLETABLET10017
62756-518-13CARBIDOPA AND LEVODOPA500 in 1 BOTTLETABLET50017
62756-518-18CARBIDOPA AND LEVODOPA1000 in 1 BOTTLETABLET100017
62756-518-83CARBIDOPA AND LEVODOPA30 in 1 BOTTLETABLET3017
62756-518-88CARBIDOPA AND LEVODOPA100 in 1 BOTTLETABLET10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-518-13EA - Each62756-518cff62812-4c6b-41e9-83b4-798e9857f6a412012-07-24
62756-518-18EA - Each62756-5183ab47088-7305-4bf4-8110-7c0494ddd1fb12012-07-24
62756-518-88EA - Each62756-518eb062f8f-2a91-4dbe-ab13-53f0759c3fad12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-518CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]17Current NDC, Legacy NDC, 5 package rows20210814_829c35f9-ace0-11dd-8800-f3e252b43544.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN7ea16ee0-c429-4b6c-aa67-2d22a934f704103
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSNff42deb9-56b2-4d9d-8df6-23b9fd4ad66d103
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD7ea16ee0-c429-4b6c-aa67-2d22a934f704103
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCDff42deb9-56b2-4d9d-8df6-23b9fd4ad66d103
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSYff42deb9-56b2-4d9d-8df6-23b9fd4ad66d103
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY7ea16ee0-c429-4b6c-aa67-2d22a934f704103
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY7ea16ee0-c429-4b6c-aa67-2d22a934f704103
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSYff42deb9-56b2-4d9d-8df6-23b9fd4ad66d103
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN829c35f9-ace0-11dd-8800-f3e252b4354417
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN829c35f9-ace0-11dd-8800-f3e252b4354417
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN829c35f9-ace0-11dd-8800-f3e252b4354417
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD829c35f9-ace0-11dd-8800-f3e252b4354417
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD829c35f9-ace0-11dd-8800-f3e252b4354417
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD829c35f9-ace0-11dd-8800-f3e252b4354417
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY829c35f9-ace0-11dd-8800-f3e252b4354417
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY829c35f9-ace0-11dd-8800-f3e252b4354417
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY829c35f9-ace0-11dd-8800-f3e252b4354417
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY829c35f9-ace0-11dd-8800-f3e252b4354417
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY829c35f9-ace0-11dd-8800-f3e252b4354417
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY829c35f9-ace0-11dd-8800-f3e252b4354417
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSNad2ab0c4-188b-f025-e053-2a95a90a28163
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCDad2ab0c4-188b-f025-e053-2a95a90a28163
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSYad2ab0c4-188b-f025-e053-2a95a90a28163
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSYad2ab0c4-188b-f025-e053-2a95a90a28163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-518-0862756051808100 TABLET in 1 BOTTLE (62756-518-08) 100 tablet2008-10-280000-00-00NoNoCurrent
62756-518-1362756051813500 TABLET in 1 BOTTLE (62756-518-13) 500 tablet2008-10-280000-00-00NoNoCurrent
62756-518-18627560518181000 TABLET in 1 BOTTLE (62756-518-18) 1000 tablet2008-10-280000-00-00NoNoCurrent
62756-518-836275605188330 TABLET in 1 BOTTLE (62756-518-83) 30 tablet2008-10-280000-00-00NoNoCurrent
62756-518-8862756051888100 TABLET in 1 BOTTLE (62756-518-88) 100 tablet2008-10-280000-00-00NoNoCurrent