Prescription drug · ANDA
Calcitrene (Calcipotriene) NDC 51672-5278
Calcipotriene .05 mg/g · Ointment · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-5278-3 | 5167252780351672527803 | 1 TUBE in 1 CARTON (51672-5278-3) / 60 g in 1 TUBEMarketed from Mar 24, 2010 | |
| 51672-5278-4 | 5167252780451672527804 | 1 TUBE in 1 CARTON (51672-5278-4) / 120 g in 1 TUBEMarketed from Mar 24, 2010 | |
| 51672-5278-5 | 5167252780551672527805 | 10 TUBE in 1 CARTON (51672-5278-5) / 5 g in 1 TUBEMarketed from Mar 24, 2010 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Calcitrene
- Generic name (nonproprietary)
- calcipotriene
- Active ingredients
- Calcipotriene — .05 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090633
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin D (Chemical structure)
- Identifiers
- Product ID 51672-5278_5698b4f1-b04f-1b1f-e063-6394a90ae022SPL ID 5698b4f1-b04f-1b1f-e063-6394a90ae022SPL set ID 94d4f46a-f254-4fe2-b4bd-7a533d6324feRxCUI 198373, 1013636UNII 143NQ3779B
- 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
N451672527803followed by a unit qualifier and the quantityPackage 51672-5278-03. 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 Calcitrene ® (calcipotriene) ointment, 0.005%, is indicated for the treatment of plaque psoriasis in adults. 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.
About NDC 51672-5278
- What is NDC 51672-5278?
- 51672-5278 is the product NDC for Calcitrene (calcipotriene), Calcipotriene .05 mg/g ointment, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calcitrene (Calcipotriene).
- What is the active ingredient?
- Calcipotriene.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Calcitrene?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 090633
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 .05 mg/g | OintmentTopical | Sun Pharmaceutical Industries, Inc. | 51672-4154 |
| Calcipotriene | Calcipotriene 50 ug/g | OintmentTopical | Glenmark Pharmaceuticals Inc., USA | 68462-310 |