Calcitriol
- Product NDC
- 70954-831
- 11-digit product format
- 709540831
- Labeler code
- 70954
- Product ID
- 70954-831_bdb9c0d4-bdb3-4174-a4d9-55c423f38476
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcitriol
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA021068
- Marketing category
- NDA
- Marketing start
- 2026-05-13
- Substance
- CALCITRIOL
- Active strength
- 1 ug/mL
- Pharmacologic classes
- Cholecalciferol [CS], Vitamin D3 Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Calcitriol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CALCITRIOL | 1 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FXC9231JVH |
| Rxcui | 313932 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-831-10 | Calcitriol | 15 mL in 1 BOTTLE, GLASS | SOLUTION | 15 | | 1 |
| 70954-831-10 | Calcitriol | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-831-10 | 70954083110 | 1 BOTTLE, GLASS in 1 CARTON (70954-831-10) / 15 mL in 1 BOTTLE, GLASS | 2026-05-13 | No | No | Current |