Stalevo
- Product NDC
- 52427-842
- 11-digit product format
- 524270842
- Labeler code
- 52427
- Product ID
- 52427-842_e400f8d7-39a0-1b94-222b-73dc9403ba4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carbidopa, levodopa, and entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Almatica Pharma LLC
- Application
- NDA021485
- Marketing category
- NDA
- Marketing start
- 2020-10-05
- Marketing end
- 0000-00-00
- Substance
- CARBIDOPA; ENTACAPONE; LEVODOPA
- Active strength
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52427-842 | STALEVO (CARBIDOPA, LEVODOPA, AND ENTACAPONE) TABLET, FILM COATED [ALMATICA PHARMA LLC] | 5 | Legacy NDC | 20241011_53c488d8-4146-7563-8021-d90c931d1a95.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52427-842-01 | 52427084201 | 1 BOTTLE in 1 CARTON (52427-842-01) > 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2020-10-05 | 0000-00-00 | No | No | Current |