CARBIDOPA, LEVODOPA AND ENTACAPONE
- Product NDC
- 16571-689
- 11-digit product format
- 165710689
- Labeler code
- 16571
- Product ID
- 16571-689_4d1e7e53-059c-4a41-86b0-66d20ce660d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBIDOPA, LEVODOPA AND ENTACAPONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA213212
- Marketing category
- ANDA
- Marketing start
- 2021-08-05
- Substance
- CARBIDOPA; ENTACAPONE; LEVODOPA
- Active strength
- 12.5; 200; 50 mg/1; mg/1; mg/1
- Pharmacologic classes
- Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [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, LEVODOPA AND ENTACAPONE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CARBIDOPA | 12.5 mg/1 |
| ENTACAPONE | 200 mg/1 |
| LEVODOPA | 50 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | MNX7R8C5VO, 46627O600J, 4975G9NM6T |
| Rxcui | 403850, 403851, 403852, 730988, 810083, 810090 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5ce6fab2-d006-4589-8ba0-02cee499cc60 | Product name | 2 | 20260128 |
| ebf3b793-6fcd-797b-9d2e-c3faf6d29442 | Product name | 5 | 20251106 |
| 162160fe-5ea6-4f9d-aa38-c4b780c57046 | Product name | 1 | 20250515 |
| 0e5ae331-9620-4d1f-8061-7c437c7f1c42 | Product name | 1 | 20250312 |
| 028fdaca-77da-0dfe-e445-7dfc440fc97e | Product name | 4 | 20250224 |
| 7d015b89-35e8-b484-e5db-c0c44814f63c | Product name | 7 | 20241218 |
| 6a098371-84f5-7ced-0ac5-ed90d535b476 | Product name | 6 | 20220927 |
| de702a02-e9c0-4daf-9101-e44f2c0d4e66 | Product name | 1 | 20220609 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 681917df-580c-4199-896d-b739fbb25ed3 | Product name | 1 | 20190412 |
| 7d015b89-35e8-b484-e5db-c0c44814f63c | Product name | 4 | 20171212 |
| 1fa100ae-9ab3-4df0-afe7-33ab01fd4a41 | Product name | 1 | 20150313 |
| 88839c8d-b65b-4a50-997b-4c74539855ff | Product name | 1 | 20150313 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16571-689-01 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16571-689-01 | EA - Each | 16571-689 | 92e39b32-0205-4950-8881-26a473803dca | 1 | 2022-03-09 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403850 | carbidopa 12.5 MG / levodopa 50 MG / entacapone 200 MG Oral Tablet | PSN | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 810090 | carbidopa 18.75 MG / levodopa 75 MG / entacapone 200 MG Oral Tablet | PSN | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 403851 | carbidopa 25 MG / levodopa 100 MG / entacapone 200 MG Oral Tablet | PSN | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 810083 | carbidopa 31.25 MG / levodopa 125 MG / entacapone 200 MG Oral Tablet | PSN | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 403852 | carbidopa 37.5 MG / levodopa 150 MG / entacapone 200 MG Oral Tablet | PSN | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 730988 | carbidopa 50 MG / levodopa 200 MG / entacapone 200 MG Oral Tablet | PSN | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 403850 | carbidopa 12.5 MG / entacapone 200 MG / levodopa 50 MG Oral Tablet | SCD | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 810090 | carbidopa 18.75 MG / entacapone 200 MG / levodopa 75 MG Oral Tablet | SCD | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 403851 | carbidopa 25 MG / entacapone 200 MG / levodopa 100 MG Oral Tablet | SCD | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 810083 | carbidopa 31.25 MG / entacapone 200 MG / levodopa 125 MG Oral Tablet | SCD | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 403852 | carbidopa 37.5 MG / entacapone 200 MG / levodopa 150 MG Oral Tablet | SCD | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 730988 | carbidopa 50 MG / entacapone 200 MG / levodopa 200 MG Oral Tablet | SCD | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 403850 | Carbidopa 12.5 MG / entacapone 200 MG / L-DOPA 50 MG Oral Tablet | SY | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 810090 | Carbidopa 18.75 MG / entacapone 200 MG / L-DOPA 75 MG Oral Tablet | SY | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 403851 | Carbidopa 25 MG / entacapone 200 MG / L-DOPA 100 MG Oral Tablet | SY | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 810083 | Carbidopa 31.25 MG / entacapone 200 MG / L-DOPA 125 MG Oral Tablet | SY | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 403852 | Carbidopa 37.5 MG / entacapone 200 MG / L-DOPA 150 MG Oral Tablet | SY | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
| 730988 | Carbidopa 50 MG / entacapone 200 MG / L-DOPA 200 MG Oral Tablet | SY | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16571-689-01 | 16571068901 | 100 TABLET, FILM COATED in 1 BOTTLE (16571-689-01) | 2021-08-05 | 0000-00-00 | No | No | Current |