Cinacalcet
- Product NDC
- 50268-188
- 11-digit product format
- 502680188
- Labeler code
- 50268
- Product ID
- 50268-188_4d2f2aa7-d529-e8e9-e063-6294a90aab14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cinacalcet
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA209226
- Marketing category
- ANDA
- Marketing start
- 2026-03-16
- 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 |
|---|
| 50268-188-11 | Cinacalcet | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 1 |
| 50268-188-12 | Cinacalcet | 20 in 1 BOX | TABLET, FILM COATED | 20 | | 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 |
|---|
| 50268-188-11 | 50268018811 | 1 in 1 BLISTER PACK | | | | | Historical |
| 50268-188-12 | 50268018812 | 20 BLISTER PACK in 1 BOX (50268-188-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-188-11) | 20 blister pack | 2026-03-16 | No | No | Historical |