Prescription drug · ANDA
Calcipotriene NDC 0713-0318
Calcipotriene .05 mg/mL · Solution · Topical · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0318-53 | 0071303185300713031853 | 1 BOTTLE in 1 CARTON (0713-0318-53) / 60 mL in 1 BOTTLEMarketed from Mar 24, 2011 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — .05 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078468
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin D (Chemical structure)
- Identifiers
- Product ID 0713-0318_ed81406a-8c10-5c33-e053-2a95a90a941fSPL ID ed81406a-8c10-5c33-e053-2a95a90a941fSPL set ID 21378c25-5622-8bf7-1a8c-b05940a846a0RxCUI 308865UNII 143NQ3779BUPC 0307130318532
- 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
N400713031853followed by a unit qualifier and the quantityPackage 00713-0318-53. 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 Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. 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 0713-0318
- What is NDC 0713-0318?
- 0713-0318 is the product NDC for Calcipotriene, Calcipotriene .05 mg/mL solution, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. 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/g | OintmentTopical | Sun Pharmaceutical Industries, Inc. | 51672-4154 | 51672-4154-0351672-4154-0451672-4154-05 |
| 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 078468
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 |
|---|---|---|---|---|
| Pellixcalcipotriene | Calcipotriene .05 mg/mL | SolutionTopical | Perfero Pharma, Inc. | 87143-300 |