Carbidopa and Levodopa
- Product NDC
- 50228-461
- 11-digit product format
- 502280461
- Labeler code
- 50228
- Product ID
- 50228-461_cea3f5f1-014d-0c1d-e053-2995a90a7f01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbidopa and Levodopa
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals Inc
- Application
- ANDA214091
- Marketing category
- ANDA
- Marketing start
- 2021-10-05
- Substance
- CARBIDOPA; LEVODOPA
- Active strength
- 50; 200 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| Ingredient | Strength |
|---|
| CARBIDOPA | 50 mg/1 |
| LEVODOPA | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MNX7R8C5VO, 46627O600J |
| Rxcui | 308988, 308989 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-461-01 | Carbidopa and Levodopa | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 1 |
| 50228-461-10 | Carbidopa and Levodopa | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 1 |
| 50228-461-30 | Carbidopa and Levodopa | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-461 | CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS INC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20211020_1b17ab1e-f3c1-4343-ba28-e2901cd97d43.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50228-461-01 | 50228046101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-461-01) | 2021-10-05 | 0000-00-00 | No | No | Current |
| 50228-461-10 | 50228046110 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-461-10) | 2021-10-05 | 0000-00-00 | No | No | Current |
| 50228-461-30 | 50228046130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-461-30) | 2021-10-05 | 0000-00-00 | No | No | Current |