Cinacalcet
- Product NDC
- 47335-379
- 11-digit product format
- 473350379
- Labeler code
- 47335
- Product ID
- 47335-379_fb601aec-aba6-4bec-a98d-51e556fef95c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cinacalcet
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA207008
- Marketing category
- ANDA
- Marketing start
- 2019-05-15
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cinacalcet
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CINACALCET HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1K860WSG25 |
| Rxcui | 432400, 432401, 432402 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-379-83 | Cinacalcet | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-379 | CINACALCET TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20211221_092553cf-1bcd-4c19-9adf-b46f2bda5c9e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-379-83 | 47335037983 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-379-83) | 2019-05-15 | 0000-00-00 | No | No | Current |