Prescription drug · ANDA
Calcipotriene NDC 51672-4154
Calcipotriene .05 mg/g · Ointment · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-4154-3 | 51672415403 | 1 TUBE in 1 CARTON (51672-4154-3) / 60 g in 1 TUBEMarketed from Mar 24, 2010 | |
| 51672-4154-4 | 51672415404 | 1 TUBE in 1 CARTON (51672-4154-4) / 120 g in 1 TUBEMarketed from Mar 24, 2010 | |
| 51672-4154-5 | 51672415405 | 10 TUBE in 1 CARTON (51672-4154-5) / 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)
- Calcipotriene
- 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 51672-4154_5698a2a4-f8fb-0b4b-e063-6394a90ab60cSPL ID 5698a2a4-f8fb-0b4b-e063-6394a90ab60cSPL set ID 277d843a-0ea9-429d-813d-49ed72dafb64RxCUI 198373UNII 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
N451672415403followed by a unit qualifier and the quantityPackage 51672-4154-03. 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 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 51672-4154
- What is NDC 51672-4154?
- 51672-4154 is the product NDC for 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?
- 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 Calcipotriene?
- 7 other product NDCs are listed under this name. See all Calcipotriene NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calcipotriene products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| calcipotriene | Calcipotriene 50 ug/g | Aerosol, FoamTopical | Mayne Pharma | 51862-512 | 51862-0512-60 |
| calcipotriene | Calcipotriene 50 ug/g | CreamTopical | Glenmark Pharmaceuticals Inc.,USA | 68462-501 | 68462-0501-6568462-0501-66 |
| calcipotriene | Calcipotriene 50 ug/g | CreamTopical | Northstar Rx LLC | 16714-763 | 16714-0763-0116714-0763-02 |
| calcipotriene | Calcipotriene 50 ug/g | OintmentTopical | Prasco Laboratories | 66993-878 | 66993-0878-6166993-0878-78 |
| Calcipotriene | Calcipotriene .05 mg/mL | SolutionTopical | Cosette Pharmaceuticals, Inc. | 0713-0318 | 00713-0318-53 |
| Calcipotriene | Calcipotriene 50 ug/g | OintmentTopical | Glenmark Pharmaceuticals Inc., USA | 68462-310 | 68462-0310-6568462-0310-66 |
| Calcipotriene | Calcipotriene 50 ug/g | CreamTopical | Prasco Laboratories | 66993-877 | 66993-0877-6166993-0877-78 |
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 50 ug/g | OintmentTopical | Glenmark Pharmaceuticals Inc., USA | 68462-310 |
| Calcitrenecalcipotriene | Calcipotriene .05 mg/g | OintmentTopical | Sun Pharmaceutical Industries, Inc. | 51672-5278 |