Calcitriol
- Product NDC
- 43353-034
- 11-digit product format
- 433530034
- Labeler code
- 43353
- Product ID
- 43353-034_d2e1ed0f-752a-4471-820d-291a99f751e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Calcitriol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076917
- Marketing category
- ANDA
- Marketing start
- 2006-03-27
- Marketing end
- 0000-00-00
- Substance
- CALCITRIOL
- Active strength
- 0 ug/1
- Pharmacologic classes
- Cholecalciferol [CS],Vitamin D3 Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-034-09 | Calcitriol | 9000 in 1 BOTTLE, PLASTIC | CAPSULE | 9000 | | 3 |
| 43353-034-81 | Calcitriol | 800 in 1 BOTTLE, PLASTIC | CAPSULE | 800 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CALCITRIOL | ACTIVE INGREDIENT | FXC9231JVH | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| CALCITRIOL | ACTIVE MOIETY | FXC9231JVH | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| COCONUT OIL | INACTIVE INGREDIENT | Q9L0O73W7L | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-034 | CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC, 2 package rows | 20191221_167a669f-7b7e-46ea-9331-567bf19d8787.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 |
|---|
| 43353-034-09 | 43353003409 | 9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-034-09) | 9000 capsule | 2013-07-03 | 0000-00-00 | No | No | Current |
| 43353-034-81 | 43353003481 | 800 CAPSULE in 1 BOTTLE, PLASTIC (43353-034-81) | 800 capsule | 2012-08-30 | 0000-00-00 | No | No | Current |