Cinacalcet
- Product NDC
- 0904-7502
- 11-digit product format
- 009047502
- Labeler code
- 0904
- Product ID
- 0904-7502_fba26c92-e029-462f-871b-c639228c59f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cinacalcet
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA209226
- Marketing category
- ANDA
- Marketing start
- 2025-01-29
- 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 |
|---|
| 0904-7502-04 | Cinacalcet | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 2 |
| 0904-7502-04 | Cinacalcet | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7502 | CINACALCET TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20250130_0692252e-4cc6-4f16-8a54-aeacd59c3143.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7502-04 | 00904750204 | 30 BLISTER PACK in 1 CARTON (0904-7502-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2025-01-29 | No | No | Historical |