Calcitriol
- Product NDC
- 65162-519
- 11-digit product format
- 651620519
- Labeler code
- 65162
- Product ID
- 65162-519_ef9469b2-7a07-48f6-b7be-8a8ae57f08e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcitriol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA203289
- Marketing category
- ANDA
- Marketing start
- 2017-06-18
- Substance
- CALCITRIOL
- Active strength
- .25 ug/1
- 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 | .25 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FXC9231JVH |
| Rxcui | 308867, 308868 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-519-03 | Calcitriol | 30 in 1 BOTTLE | CAPSULE | 30 | | 10 |
| 65162-519-10 | Calcitriol | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 65162-519-25 | Calcitriol | 250 in 1 BOTTLE | CAPSULE | 250 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-519 | CALCITRIOL CAPSULE [AMNEAL PHARMACEUTICALS LLC] | 10 | Current NDC, Legacy NDC, 3 package rows | 20241025_b1fef137-63c5-4662-8cd9-b9e8b12bacb6.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 |
|---|
| 65162-519-03 | 65162051903 | 30 CAPSULE in 1 BOTTLE (65162-519-03) | 30 capsule | 2017-06-18 | 0000-00-00 | No | No | Current |
| 65162-519-10 | 65162051910 | 100 CAPSULE in 1 BOTTLE (65162-519-10) | 100 capsule | 2017-06-18 | 0000-00-00 | No | No | Current |
| 65162-519-25 | 65162051925 | 250 CAPSULE in 1 BOTTLE (65162-519-25) | 250 capsule | 2017-06-18 | 0000-00-00 | No | No | Current |