Prescription drug · ANDA
calcipotriene NDC 68462-501
Calcipotriene 50 ug/g · Cream · Topical · Glenmark Pharmaceuticals Inc.,USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-501-65 | 68462050165 | 1 TUBE in 1 CARTON (68462-501-65) / 60 g in 1 TUBEMarketed from Jun 10, 2015 | |
| 68462-501-66 | 68462050166 | 1 TUBE in 1 CARTON (68462-501-66) / 120 g in 1 TUBEMarketed from Jun 10, 2015 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- calcipotriene
- Generic name (nonproprietary)
- calcipotriene
- Active ingredients
- Calcipotriene — 50 ug/g
- Dosage form
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205772
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin D (Chemical structure)
- Identifiers
- Product ID 68462-501_d0707037-c9cd-4c52-a1f5-4c8f72f62010SPL ID d0707037-c9cd-4c52-a1f5-4c8f72f62010SPL set ID 7ec750f6-26ea-46bc-aa7b-174fd25253a2RxCUI 313921UNII 143NQ3779BUPC 0368462501665, 0368462501658
- Pharmacologic class
- Vitamin D Analog
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468462050165followed by a unit qualifier and the quantityPackage 68462-0501-65. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205772
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| calcipotriene | Calcipotriene 50 ug/g | CreamTopical | Northstar Rx LLC | 16714-763 |