FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
0904-7549
11-digit product format
009047549
Labeler code
0904
Product ID
0904-7549_f5d5ad01-a099-46cd-95fc-98ebc80ddc96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA073607
Marketing category
ANDA
Marketing start
2025-04-28
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
2026-12-31
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
CARBIDOPA HYDRATE25 mg/1
LEVODOPA250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46627O600J, MNX7R8C5VO
Rxcui197444, 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
0904-7549-61Carbidopa and Levodopa100 in 1 CARTONTABLET1002
0904-7549-61Carbidopa and Levodopa1 in 1 BLISTER PACKTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7549-61EA - Each0904-7549970808fb-48aa-468e-90cf-e7533c2e736712025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7549CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]2Current NDC, 2 package rows20250430_3f6d393e-ac84-4a3c-a837-199d1ec71fd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN19d853e2-b8bd-490e-b8d2-b38bec68a1393
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN19d853e2-b8bd-490e-b8d2-b38bec68a1393
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD19d853e2-b8bd-490e-b8d2-b38bec68a1393
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD19d853e2-b8bd-490e-b8d2-b38bec68a1393
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY19d853e2-b8bd-490e-b8d2-b38bec68a1393
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY19d853e2-b8bd-490e-b8d2-b38bec68a1393
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY19d853e2-b8bd-490e-b8d2-b38bec68a1393
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY19d853e2-b8bd-490e-b8d2-b38bec68a1393
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 startSampleExclude flagStatus
0904-7549-6100904754961100 BLISTER PACK in 1 CARTON (0904-7549-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2025-04-28NoNoCurrent