Carbidopa and Levodopa

Product NDC
70518-4621
11-digit product format
705184621
Labeler code
70518
Product ID
70518-4621_5039353f-cfd8-14e1-e063-6294a90a6d78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA203312
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2026-04-24
Substance
CARBIDOPA; LEVODOPA
Active strength
48.75; 195 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
CARBIDOPA48.75 mg/1
LEVODOPA195 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMNX7R8C5VO, 46627O600J
Rxcui1600914

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
70518-4621-0Carbidopa and Levodopa50 in 1 BOXCAPSULE, EXTENDED RELEASE501
70518-4621-1Carbidopa and Levodopa1 in 1 POUCHCAPSULE, EXTENDED RELEASE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600914carbidopa 48.75 MG / levodopa 195 MG 8HR Extended Release Oral CapsulePSN9ac804f1-7e15-48bc-8ae9-25181a629dd41
16009148 HR carbidopa 48.75 MG / levodopa 195 MG Extended Release Oral CapsuleSCD9ac804f1-7e15-48bc-8ae9-25181a629dd41
16009148 HR Carbidopa 48.75 MG / L-DOPA 195 MG Extended Release Oral CapsuleSY9ac804f1-7e15-48bc-8ae9-25181a629dd41
1600914carbidopa 48.75 MG / levodopa 195 MG 8 HR Extended Release Oral CapsuleSY9ac804f1-7e15-48bc-8ae9-25181a629dd41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4621-07051846210050 POUCH in 1 BOX (70518-4621-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4621-1) 50 pouch2026-04-24NoNoHistorical
70518-4621-1705184621011 in 1 POUCHHistorical