FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
71610-647
11-digit product format
716100647
Labeler code
71610
Product ID
71610-647_188d3827-60b2-4893-a8db-21433377eb1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA214092
Marketing category
ANDA
Marketing start
2021-05-07
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
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
CARBIDOPA25 mg/1
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMNX7R8C5VO, 46627O600J
Rxcui197444

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
71610-647-60Carbidopa and Levodopa90 in 1 BOTTLETABLET903
71610-647-80Carbidopa and Levodopa180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-647-60EA - Each71610-64759e5806d-8536-459c-828d-1aeda06b928d12022-07-06
71610-647-80EA - Each71610-647473b879b-d101-4950-8682-21adbe4e717a12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-647CARBIDOPA AND LEVODOPA TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 2 package rows20220512_289ca0b7-1b4f-4653-b329-066447d18c13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN289ca0b7-1b4f-4653-b329-066447d18c133
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD289ca0b7-1b4f-4653-b329-066447d18c133
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY289ca0b7-1b4f-4653-b329-066447d18c133
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY289ca0b7-1b4f-4653-b329-066447d18c133

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-647-607161006476090 TABLET in 1 BOTTLE (71610-647-60) 90 tablet2022-05-020000-00-00NoNoCurrent
71610-647-8071610064780180 TABLET in 1 BOTTLE (71610-647-80) 180 tablet2022-05-020000-00-00NoNoCurrent