Calcitriol
- Product NDC
- 0143-9728
- 11-digit product format
- 001439728
- Labeler code
- 0143
- Product ID
- 0143-9728_e3d84b78-e69d-4898-811c-c00ad67ea830
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcitriol
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- West-ward Pharmaceutical Corp
- Application
- ANDA077102
- Marketing category
- ANDA
- Marketing start
- 2006-02-08
- Marketing end
- 0000-00-00
- Substance
- CALCITRIOL
- Active strength
- 1 ug/mL
- Pharmacologic classes
- Cholecalciferol [CS],Vitamin D3 Analog [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 09b728d3-9521-67a6-95fe-30969d1d5187 | Product name | 5 | 20240828 |
| 5f07db61-095c-acca-e8e9-d0916b4c1947 | Product name | 2 | 20200616 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| 98f556da-44be-c658-496e-47884da4e67b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0143-9728-05 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d757-8e05-e053-dbdaa90a074a | Calcitriol Injection Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9728-05 | Calcitriol | 1 mL in 1 AMPULE | INJECTION | 1 | 3 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CALCITRIOL | ACTIVE INGREDIENT | FXC9231JVH | CALCITRIOL INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 3 | |
| CALCITRIOL | ACTIVE MOIETY | FXC9231JVH | CALCITRIOL INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | CALCITRIOL INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 3 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | CALCITRIOL INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 3 | |
| SODIUM ASCORBATE | INACTIVE INGREDIENT | S033EH8359 | CALCITRIOL INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 3 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CALCITRIOL INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 3 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | CALCITRIOL INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 3 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | CALCITRIOL INJECTION [WEST-WARD PHARMACEUTICAL CORP] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308869 | calcitriol 1 MCG in 1 ML Injection | PSN | add1e536-b6ed-4ba1-abd6-084b6845e3a4 | 3 |
| 308869 | 1 ML calcitriol 0.001 MG/ML Injection | SCD | add1e536-b6ed-4ba1-abd6-084b6845e3a4 | 3 |
| 308869 | calcitriol 1 MCG per 1 ML Injection | SY | add1e536-b6ed-4ba1-abd6-084b6845e3a4 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 0143-9728-05 | 00143972805 | 1 mL in 1 AMPULE | 1 ml | Historical |