Cinacalcet
- Product NDC
- 70518-4615
- 11-digit product format
- 705184615
- Labeler code
- 70518
- Product ID
- 70518-4615_50343b7d-69e1-ea69-e063-6294a90abe0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cinacalcet
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209226
- Marketing category
- ANDA
- Marketing start
- 2026-04-23
- Substance
- CINACALCET HYDROCHLORIDE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cinacalcet
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CINACALCET HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1K860WSG25 |
| Rxcui | 432402 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4615-0 | Cinacalcet | 50 in 1 BOX | TABLET, FILM COATED | 50 | | 1 |
| 70518-4615-1 | Cinacalcet | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4615-0 | 70518461500 | 50 POUCH in 1 BOX (70518-4615-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4615-1) | 50 pouch | 2026-04-23 | No | No | Current |
| 70518-4615-1 | 70518461501 | 1 in 1 POUCH | | | | | Historical |