Rocaltrol
- Product NDC
- 43353-633
- 11-digit product format
- 433530633
- Labeler code
- 43353
- Product ID
- 43353-633_e3436ec4-da38-4e59-a2cf-e573bb00925a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- calcitriol
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, Inc.
- Application
- NDA018044
- Marketing category
- NDA
- Marketing start
- 2009-08-10
- 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
- 2019-12-31
- 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 |
|---|
| 43353-633-81 | Rocaltrol | 800 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 800 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CALCITRIOL | ACTIVE INGREDIENT | FXC9231JVH | ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| CALCITRIOL | ACTIVE MOIETY | FXC9231JVH | ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| COCONUT OIL | INACTIVE INGREDIENT | Q9L0O73W7L | ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-633 | ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | Legacy NDC, 1 package rows | 20121130_1b2aa7df-0f38-460e-b1f1-d7473be4ab3c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-633-81 | 43353063381 | 800 in 1 BOTTLE, PLASTIC | Historical |