Prescription drug · ANDA
Calcipotriene and Betamethasone Dipropionate NDC 51672-1402
Calcipotriene 50 ug/g; Betamethasone dipropionate 50 mg/g · Suspension · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-1402-4 | 5167214020451672140204 | 1 BOTTLE in 1 CARTON (51672-1402-4) / 60 g in 1 BOTTLEMarketed from Sep 2, 2020 | |
| 51672-1402-8 | 5167214020851672140208 | 2 BOTTLE in 1 CARTON (51672-1402-8) / 60 g in 1 BOTTLEMarketed from Sep 2, 2020 |
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 and Betamethasone Dipropionate
- Generic name (nonproprietary)
- calcipotriene and betamethasone dipropionate
- Active ingredients
- Calcipotriene — 50 ug/gBetamethasone dipropionate — 50 mg/g
- Dosage form
- Suspension
- 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 213269
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Vitamin D (Chemical structure)
- Identifiers
- Product ID 51672-1402_38e5b828-cecd-c95b-e063-6394a90ae2e0SPL ID 38e5b828-cecd-c95b-e063-6394a90ae2e0SPL set ID 1d0ab2e6-1ab1-4d3e-ad55-7fa26446f191UNII 143NQ3779B, 826Y60901U
- Pharmacologic class
- Corticosteroid; 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
N451672140204followed by a unit qualifier and the quantityPackage 51672-1402-04. 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)
Calcipotriene and Betamethasone Dipropionate Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information. Calcipotriene and Betamethasone Dipropionate Topical Suspension is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topi…
Excerpt only. Read the full label for complete information.
About NDC 51672-1402
- What is NDC 51672-1402?
- 51672-1402 is the product NDC for Calcipotriene and Betamethasone Dipropionate, Calcipotriene 50 ug/g; Betamethasone dipropionate 50 mg/g suspension, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calcipotriene and Betamethasone Dipropionate.
- What is the active ingredient?
- Calcipotriene, Betamethasone dipropionate.
- 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 and Betamethasone Dipropionate?
- 6 other product NDCs are listed under this name. See all Calcipotriene and Betamethasone Dipropionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calcipotriene and Betamethasone Dipropionate 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 and betamethasone dipropionate | Betamethasone dipropionate .5 mg/g; Calcipotriene 50 ug/g | SuspensionTopical | Cosette Pharmaceuticals, Inc. | 0713-0848 | 00713-0848-6000713-0848-92 |
| Calcipotriene and Betamethasone Dipropionatecalcipotriene, betamethasone dipropionate | Calcipotriene 50 ug/g; Betamethasone dipropionate .643 mg/g | OintmentTopical | Padagis Israel Pharmaceuticals Ltd | 45802-816 | 45802-0816-0145802-0816-96 |
| Calcipotriene and Betamethasone Dipropionatecalcipotriene, betamethasone dipropionate | Calcipotriene 50 ug/g; Betamethasone dipropionate .643 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-2520 | 63629-2520-01 |
| Calcipotriene and Betamethasone Dipropionatecalcipotriene, betamethasone dipropionate | Calcipotriene 50 ug/g; Betamethasone dipropionate .643 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-8617 | 63629-8617-01 |
| Calcipotriene and Betamethasone Dipropionatecalcipotriene, betamethasone dipropionate | Calcipotriene 50 ug/g; Betamethasone dipropionate .643 mg/g | OintmentTopical | Bryant Ranch Prepack | 72162-1428 | 72162-1428-0172162-1428-06 |
| Calcipotriene and Betamethasone Dipropionate | Calcipotriene monohydrate 50 ug/g; Betamethasone dipropionate .5 mg/g | OintmentTopical | Prasco Laboratories | 66993-938 | 66993-0938-6166993-0938-65 |