FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
16571-157
11-digit product format
165710157
Labeler code
16571
Product ID
16571-157_bf8b1cec-9b24-4102-b948-08c988bfca91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA078893
Marketing category
ANDA
Marketing start
2025-01-08
Substance
CARBIDOPA; LEVODOPA
Active strength
10; 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
CARBIDOPA10 mg/1
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46627O600J, MNX7R8C5VO
Rxcui476399, 476515, 483090

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-157-01Carbidopa and Levodopa100 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-157-01EA - Each16571-1570ed70b58-126d-42ee-b68f-14653649ac8912025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-157CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [RISING PHARMA HOLDINGS, INC.]2Current NDC, 1 package rows20250413_302bfe03-d222-4a87-80ff-f2dbfb9a07f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483090carbidopa 10 MG / levodopa 100 MG Disintegrating Oral TabletPSN302bfe03-d222-4a87-80ff-f2dbfb9a07f44
476399carbidopa 25 MG / levodopa 100 MG Disintegrating Oral TabletPSN302bfe03-d222-4a87-80ff-f2dbfb9a07f44
476515carbidopa 25 MG / levodopa 250 MG Disintegrating Oral TabletPSN302bfe03-d222-4a87-80ff-f2dbfb9a07f44
483090carbidopa 10 MG / levodopa 100 MG Disintegrating Oral TabletSCD302bfe03-d222-4a87-80ff-f2dbfb9a07f44
476399carbidopa 25 MG / levodopa 100 MG Disintegrating Oral TabletSCD302bfe03-d222-4a87-80ff-f2dbfb9a07f44
476515carbidopa 25 MG / levodopa 250 MG Disintegrating Oral TabletSCD302bfe03-d222-4a87-80ff-f2dbfb9a07f44
483090Carbidopa 10 MG / L-DOPA 100 MG Disintegrating Oral TabletSY302bfe03-d222-4a87-80ff-f2dbfb9a07f44
476399Carbidopa 25 MG / L-DOPA 100 MG Disintegrating Oral TabletSY302bfe03-d222-4a87-80ff-f2dbfb9a07f44
476515Carbidopa 25 MG / L-DOPA 250 MG Disintegrating Oral TabletSY302bfe03-d222-4a87-80ff-f2dbfb9a07f44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16571-157-0116571015701100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (16571-157-01) 2025-01-08NoNoHistorical