Cinacalcet
- Product NDC
- 63629-8764
- 11-digit product format
- 636298764
- Labeler code
- 63629
- Product ID
- 63629-8764_2750d293-5089-4267-9e36-9e95a3b85c59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cinacalcet
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA210570
- Marketing category
- ANDA
- Marketing start
- 2019-05-18
- 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
- 2026-12-31
- 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 | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1K860WSG25 |
| Rxcui | 432401 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8764-1 | Cinacalcet | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 105 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8764 | CINACALCET TABLET, FILM COATED [BRYANT RANCH PREPACK] | 105 | Current NDC, Legacy NDC, 1 package rows | 20231031_c288922b-3258-4c1c-bd8a-32a41dd43a63.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 |
|---|
| 63629-8764-1 | 63629876401 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-8764-1) | 2019-05-18 | 0000-00-00 | No | No | Current |