Cinacalcet
- Product NDC
- 64380-884
- 11-digit product format
- 643800884
- Labeler code
- 64380
- Product ID
- 64380-884_40332509-df24-41a0-a75c-86d556cf0c50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cinacalcet
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA209226
- Marketing category
- ANDA
- Marketing start
- 2019-08-22
- 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
- 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 | 60 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 |
|---|
| 64380-884-04 | Cinacalcet | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-884 | CINACALCET TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED] | 14 | Current NDC, Legacy NDC, 1 package rows | 20200717_0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d7.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 |
|---|
| 64380-884-04 | 64380088404 | 30 TABLET, FILM COATED in 1 BOTTLE (64380-884-04) | 2019-08-22 | 0000-00-00 | No | No | Current |