FDA.reportPublic FDA data

Carbidopa and levodopa

Product NDC
72888-155
11-digit product format
728880155
Labeler code
72888
Product ID
72888-155_519a4143-7efb-81ab-e063-6394a90a219b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA217482
Marketing category
ANDA
Marketing start
2024-06-04
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
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
LEVODOPA100 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
72888-155-00Carbidopa and levodopa1000 in 1 BOTTLETABLET, EXTENDED RELEASE10006
72888-155-01Carbidopa and levodopa100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
72888-155-05Carbidopa and levodopa500 in 1 BOTTLETABLET, EXTENDED RELEASE5006
72888-155-30Carbidopa and levodopa30 in 1 BOTTLETABLET, EXTENDED RELEASE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-155-01EA - Each72888-15576fe3690-578f-4e86-b8a9-09da80aa466212024-09-09
72888-155-30EA - Each72888-155e2c5bd5d-5053-4666-b6ff-8a48b546de8212024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-155CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ADVAGEN PHARMA LTD]3Current NDC, 4 package rows20240713_5b6519ff-d1af-402b-83eb-b4fce6743a18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSN5b6519ff-d1af-402b-83eb-b4fce6743a186
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletPSN5b6519ff-d1af-402b-83eb-b4fce6743a186
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCD5b6519ff-d1af-402b-83eb-b4fce6743a186
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletSCD5b6519ff-d1af-402b-83eb-b4fce6743a186
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSY5b6519ff-d1af-402b-83eb-b4fce6743a186
308989carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral TabletSY5b6519ff-d1af-402b-83eb-b4fce6743a186
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSY5b6519ff-d1af-402b-83eb-b4fce6743a186
308989Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral TabletSY5b6519ff-d1af-402b-83eb-b4fce6743a186

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72888-155-00728880155001000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-00) 2024-06-04NoNoCurrent
72888-155-0172888015501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-01) 2024-06-04NoNoCurrent
72888-155-0572888015505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-05) 2024-06-04NoNoCurrent
72888-155-307288801553030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-155-30) 2024-06-04NoNoCurrent