Calcitriol
- Product NDC
- 68083-316
- 11-digit product format
- 680830316
- Labeler code
- 68083
- Product ID
- 68083-316_7e6d4205-3332-4f96-b258-8ffde9119ed4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcitriol
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA211030
- Marketing category
- ANDA
- Marketing start
- 2020-02-03
- Substance
- CALCITRIOL
- Active strength
- 1 ug/mL
- Pharmacologic classes
- Cholecalciferol [CS], Vitamin D3 Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Calcitriol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CALCITRIOL | 1 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FXC9231JVH |
| Rxcui | 308869 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-316-10 | Calcitriol | 10 in 1 CARTON | INJECTION | 10 | | 4 |
| 68083-316-10 | Calcitriol | 1 mL in 1 VIAL | INJECTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-316 | CALCITRIOL INJECTION [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20221011_d9ba544c-6ca8-410d-a306-51482a8c6848.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 |
|---|
| 68083-316-10 | 68083031610 | 10 VIAL in 1 CARTON (68083-316-10) / 1 mL in 1 VIAL | 10 vial | 2020-02-03 | 0000-00-00 | No | No | Current |