FDA.reportPublic FDA data

CARBIDOPA AND LEVODOPA

Product NDC
31722-382
11-digit product format
317220382
Labeler code
31722
Product ID
31722-382_8027b1c3-6eb7-444b-95a8-8b45f6530a12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA218939
Marketing category
ANDA
Marketing start
2025-05-27
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
Rxcui197443, 197444, 197445

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
31722-382-01CARBIDOPA AND LEVODOPA100 in 1 BOTTLETABLET1002
31722-382-05CARBIDOPA AND LEVODOPA500 in 1 BOTTLETABLET5002
31722-382-10CARBIDOPA AND LEVODOPA1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-382-01EA - Each31722-3823a722039-b975-4016-b611-f4c7afc15dfb12025-07-08
31722-382-05EA - Each31722-382e3f36f10-4e72-4d93-9802-e7159e44240212025-07-08
31722-382-10EA - Each31722-382a9a2ec26-9107-4031-a3a9-f520489c262812025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-382CARBIDOPA AND LEVODOPA TABLET [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 3 package rows20250528_770ba054-fec4-4833-8096-85c3ce3ae830.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN770ba054-fec4-4833-8096-85c3ce3ae8302
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN770ba054-fec4-4833-8096-85c3ce3ae8302
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN770ba054-fec4-4833-8096-85c3ce3ae8302
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD770ba054-fec4-4833-8096-85c3ce3ae8302
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD770ba054-fec4-4833-8096-85c3ce3ae8302
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD770ba054-fec4-4833-8096-85c3ce3ae8302
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY770ba054-fec4-4833-8096-85c3ce3ae8302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-382-0131722038201100 TABLET in 1 BOTTLE (31722-382-01) 100 tablet2025-05-27NoNoHistorical
31722-382-0531722038205500 TABLET in 1 BOTTLE (31722-382-05) 500 tablet2025-05-27NoNoHistorical
31722-382-10317220382101000 TABLET in 1 BOTTLE (31722-382-10) 1000 tablet2025-05-27NoNoHistorical