Prescription drug · ANDA
calcipotriene NDC 16714-763
Calcipotriene 50 ug/g · Cream · Topical · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-763-01 | 16714076301 | 1 TUBE in 1 CARTON (16714-763-01) / 60 g in 1 TUBEMarketed from May 1, 2018 | |
| 16714-763-02 | 16714076302 | 1 TUBE in 1 CARTON (16714-763-02) / 120 g in 1 TUBEMarketed from May 1, 2018 |
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
- Labeler
- Northstar Rx LLC
- 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 16714-763_ee33f5da-8d1a-429e-aa0c-15d19353fc44SPL ID ee33f5da-8d1a-429e-aa0c-15d19353fc44SPL set ID a882ef4f-603e-4421-97ae-2c78822c767aRxCUI 313921UNII 143NQ3779BUPC 0316714763019
- 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
N416714076301followed by a unit qualifier and the quantityPackage 16714-0763-01. 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 | Glenmark Pharmaceuticals Inc.,USA | 68462-501 |