FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
46708-333
11-digit product format
467080333
Labeler code
46708
Product ID
46708-333_a85a56c5-44dd-41d4-ac1c-bdc4758406a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA210341
Marketing category
ANDA
Marketing start
2019-06-06
Substance
CARBIDOPA; 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
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
CARBIDOPA50 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
46708-333-30Carbidopa and Levodopa30 in 1 BOTTLETABLET, EXTENDED RELEASE301
46708-333-31Carbidopa and Levodopa100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
46708-333-91Carbidopa and Levodopa1000 in 1 BOTTLETABLET, EXTENDED RELEASE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-333CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, Legacy NDC, 3 package rows20190611_a85a56c5-44dd-41d4-ac1c-bdc4758406a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSNa85a56c5-44dd-41d4-ac1c-bdc4758406a41
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletPSNa85a56c5-44dd-41d4-ac1c-bdc4758406a41
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCDa85a56c5-44dd-41d4-ac1c-bdc4758406a41
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletSCDa85a56c5-44dd-41d4-ac1c-bdc4758406a41
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSYa85a56c5-44dd-41d4-ac1c-bdc4758406a41
308989carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral TabletSYa85a56c5-44dd-41d4-ac1c-bdc4758406a41
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSYa85a56c5-44dd-41d4-ac1c-bdc4758406a41
308989Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral TabletSYa85a56c5-44dd-41d4-ac1c-bdc4758406a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-333-304670803333030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-30) 2019-06-060000-00-00NoNoCurrent
46708-333-3146708033331100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-31) 2019-06-060000-00-00NoNoCurrent
46708-333-91467080333911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-333-91) 2019-06-060000-00-00NoNoCurrent