Comtan
- Product NDC
- 52427-800
- 11-digit product format
- 524270800
- Labeler code
- 52427
- Product ID
- 52427-800_844b1b83-2bed-8e50-9c9d-9bb4cb3ab368
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Almatica Pharma LLC
- Application
- NDA020796
- Marketing category
- NDA
- Marketing start
- 2020-10-05
- Marketing end
- 0000-00-00
- Substance
- ENTACAPONE
- Active strength
- 200 mg/1
- Pharmacologic classes
- 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 |
|---|
| 52427-800 | COMTAN (ENTACAPONE) TABLET, FILM COATED [ALMATICA PHARMA LLC] | 5 | Legacy NDC | 20241010_3b45ebd7-ca36-b691-fea2-652858a5c590.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52427-800-01 | 52427080001 | 1 BOTTLE in 1 CARTON (52427-800-01) > 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2020-10-05 | 0000-00-00 | No | No | Current |