Carbidopa and Levodopa
- Product NDC
- 50228-459
- 11-digit product format
- 502280459
- Labeler code
- 50228
- Product ID
- 50228-459_3b66d16c-654c-4dcb-ad04-3503aa7f1ca5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbidopa and Levodopa
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals Inc
- Application
- ANDA214092
- Marketing category
- ANDA
- Marketing start
- 2021-05-07
- Substance
- CARBIDOPA; LEVODOPA
- Active strength
- 25; 250 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| Ingredient | Strength |
|---|
| CARBIDOPA | 25 mg/1 |
| LEVODOPA | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MNX7R8C5VO, 46627O600J |
| Rxcui | 197443, 197444, 197445 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-459-01 | Carbidopa and Levodopa | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 50228-459-05 | Carbidopa and Levodopa | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 50228-459-10 | Carbidopa and Levodopa | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
| 50228-459-30 | Carbidopa and Levodopa | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-459 | CARBIDOPA AND LEVODOPA TABLET [SCIEGEN PHARMACEUTICALS INC] | 2 | Current NDC, Legacy NDC, 4 package rows | 20230108_a32afa84-7bc0-4bd3-bc50-55d738f3d7ce.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50228-459-01 | 50228045901 | 100 TABLET in 1 BOTTLE (50228-459-01) | 100 tablet | 2021-05-07 | 0000-00-00 | No | No | Current |
| 50228-459-05 | 50228045905 | 500 TABLET in 1 BOTTLE (50228-459-05) | 500 tablet | 2021-05-07 | 0000-00-00 | No | No | Current |
| 50228-459-10 | 50228045910 | 1000 TABLET in 1 BOTTLE (50228-459-10) | 1000 tablet | 2021-05-07 | 0000-00-00 | No | No | Current |
| 50228-459-30 | 50228045930 | 30 TABLET in 1 BOTTLE (50228-459-30) | 30 tablet | 2021-05-07 | 0000-00-00 | No | No | Current |