FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
48433-016
11-digit product format
484330016
Labeler code
48433
Product ID
48433-016_4d642d35-3931-745e-e063-6294a90a8e63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Safecor Health, LLC
Application
ANDA075091
Marketing category
ANDA
Marketing start
2026-03-13
Substance
CARBIDOPA HYDRATE; LEVODOPA
Active strength
50; 200 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
CARBIDOPA HYDRATE50 mg/1
LEVODOPA200 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
48433-016-01Carbidopa and Levodopa1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE12
48433-016-20Carbidopa and Levodopa100 in 1 CARTONTABLET, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-016-20EA - Each48433-01628addd70-d494-4cd3-8721-988e770df31112026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSN015bc056-ee86-4006-ae7c-689b95e566f42
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletPSN015bc056-ee86-4006-ae7c-689b95e566f42
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCD015bc056-ee86-4006-ae7c-689b95e566f42
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletSCD015bc056-ee86-4006-ae7c-689b95e566f42
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSY015bc056-ee86-4006-ae7c-689b95e566f42
308989carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral TabletSY015bc056-ee86-4006-ae7c-689b95e566f42
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSY015bc056-ee86-4006-ae7c-689b95e566f42
308989Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral TabletSY015bc056-ee86-4006-ae7c-689b95e566f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-016-01484330016011 in 1 BLISTER PACKHistorical
48433-016-2048433001620100 BLISTER PACK in 1 CARTON (48433-016-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (48433-016-01) 100 blister pack2026-03-13NoNoHistorical