Cinacalcet
- Product NDC
- 67877-505
- 11-digit product format
- 678770505
- Labeler code
- 67877
- Product ID
- 67877-505_7dc83b54-a624-48db-ad2d-ee000a6d9c47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cinacalcet
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA210570
- Marketing category
- ANDA
- Marketing start
- 2019-05-18
- Substance
- CINACALCET HYDROCHLORIDE
- Active strength
- 90 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 | 90 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 |
|---|
| 67877-505-01 | Cinacalcet | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
| 67877-505-30 | Cinacalcet | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
| 67877-505-33 | Cinacalcet | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 11 |
| 67877-505-33 | Cinacalcet | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-505 | CINACALCET TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 10 | Current NDC, Legacy NDC, 4 package rows | 20220722_55f95ae0-84ac-4ae4-b7a0-7590ab919ae1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-505-01 | 67877050501 | 100 TABLET, FILM COATED in 1 BOTTLE (67877-505-01) | | 2019-05-18 | 0000-00-00 | No | No | Current |
| 67877-505-30 | 67877050530 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-505-30) | | 2019-05-18 | 0000-00-00 | No | No | Current |
| 67877-505-33 | 67877050533 | 10 BLISTER PACK in 1 CARTON (67877-505-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2019-05-18 | 0000-00-00 | No | No | Current |