Calcitriol
- Product NDC
- 0054-3120
- 11-digit product format
- 000543120
- Labeler code
- 0054
- Product ID
- 0054-3120_2b8745f3-5289-474e-bd44-48b59a40dd78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcitriol
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA076242
- Marketing category
- ANDA
- Marketing start
- 2003-07-18
- 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 | 313932 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-3120-41 | Calcitriol | 15 mL in 1 BOTTLE, GLASS | SOLUTION | 15 | | 15 |
| 0054-3120-41 | Calcitriol | 1 in 1 CARTON | SOLUTION | 1 | | 15 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-3120 | CALCITRIOL SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20231107_3289b482-8733-484d-b1db-d7f4cdcd1ac2.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 |
|---|
| 0054-3120-41 | 00054312041 | 1 BOTTLE, GLASS in 1 CARTON (0054-3120-41) / 15 mL in 1 BOTTLE, GLASS | 2003-07-18 | 0000-00-00 | No | No | Current |