FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
75907-021
11-digit product format
759070021
Labeler code
75907
Product ID
75907-021_3f6116d8-a60c-f7fe-c73c-b6ed1361b67f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA073607
Marketing category
ANDA
Marketing start
2024-05-01
Substance
CARBIDOPA; LEVODOPA
Active strength
25; 250 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbidopa and Levodopa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA25 mg/1
LEVODOPA250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMNX7R8C5VO, 46627O600J
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
75907-021-01Carbidopa and Levodopa100 in 1 BOTTLETABLET1004
75907-021-05Carbidopa and Levodopa500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-021-01EA - Each75907-021a5cb9ae6-adc0-46fe-93bb-c8af2a75b4ba12024-06-10
75907-021-05EA - Each75907-02116d12f2f-3e92-4fd8-96fb-7421187a144512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-021CARBIDOPA AND LEVODOPA TABLET [DR. REDDY'S LABORATORIES INC]2Current NDC, 2 package rows20250223_87ab55c9-203d-d595-3e3e-0e38f2f6d9c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN45909de3-0852-4e61-8a9e-23f8fcc2463a5
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN45909de3-0852-4e61-8a9e-23f8fcc2463a5
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN45909de3-0852-4e61-8a9e-23f8fcc2463a5
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD45909de3-0852-4e61-8a9e-23f8fcc2463a5
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD45909de3-0852-4e61-8a9e-23f8fcc2463a5
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD45909de3-0852-4e61-8a9e-23f8fcc2463a5
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY87ab55c9-203d-d595-3e3e-0e38f2f6d9c44
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN3f6d393e-ac84-4a3c-a837-199d1ec71fd22
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN3f6d393e-ac84-4a3c-a837-199d1ec71fd22
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD3f6d393e-ac84-4a3c-a837-199d1ec71fd22
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD3f6d393e-ac84-4a3c-a837-199d1ec71fd22
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY3f6d393e-ac84-4a3c-a837-199d1ec71fd22
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY3f6d393e-ac84-4a3c-a837-199d1ec71fd22
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY3f6d393e-ac84-4a3c-a837-199d1ec71fd22
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY3f6d393e-ac84-4a3c-a837-199d1ec71fd22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75907-021-0175907002101100 TABLET in 1 BOTTLE (75907-021-01) 100 tablet2024-05-01NoNoCurrent
75907-021-0575907002105500 TABLET in 1 BOTTLE (75907-021-05) 500 tablet2025-03-152027-02-28NoNoHistorical