Cinacalcet
- Product NDC
- 0378-6196
- 11-digit product format
- 003786196
- Labeler code
- 0378
- Product ID
- 0378-6196_b017fbdd-3374-405a-8f40-e43918db0f8b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cinacalcet
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA203422
- Marketing category
- ANDA
- Marketing start
- 2019-05-23
- Marketing end
- 0000-00-00
- Substance
- CINACALCET HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-6196-93 | 00378619693 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6196-93) | 2019-05-23 | 0000-00-00 | No | No | Current |