Carbidopa and Levodopa
- Product NDC
- 60219-2033
- 11-digit product format
- 602192033
- Labeler code
- 60219
- Product ID
- 60219-2033_3979736e-dac3-41a1-a3d7-d17b593a56da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBIDOPA and LEVODOPA
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA076521
- Marketing category
- ANDA
- Marketing start
- 2022-12-21
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBIDOPA HYDRATE | 25 mg/1 |
| LEVODOPA | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 46627O600J, MNX7R8C5VO |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60219-2033-1 | Carbidopa and Levodopa | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 2 |
| 60219-2033-3 | Carbidopa and Levodopa | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 2 |
| 60219-2033-5 | Carbidopa and Levodopa | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-2033 | CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20230117_0eb24333-3c11-41dd-888d-3a30d3c9d188.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60219-2033-1 | 60219203301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2033-1) | 2022-12-21 | 0000-00-00 | No | No | Current |
| 60219-2033-3 | 60219203303 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2033-3) | 2022-12-21 | 0000-00-00 | No | No | Current |
| 60219-2033-5 | 60219203305 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2033-5) | 2022-12-21 | 0000-00-00 | No | No | Current |