calcipotriene and betamethasone dipropionate NDC 0713-0848

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0848Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0848Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0713-0848-60	00713084860	1 BOTTLE in 1 CARTON (0713-0848-60) / 60 g in 1 BOTTLEMarketed from Aug 2, 2024
0713-0848-92	00713084892	2 BOTTLE in 1 CARTON (0713-0848-92) / 60 g in 1 BOTTLEMarketed from Aug 2, 2024

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 and betamethasone dipropionate
Generic name (nonproprietary): calcipotriene and betamethasone dipropionate
Active ingredients: Betamethasone dipropionate — .5 mg/gCalcipotriene — 50 ug/g
Dosage form: Suspension
Route: Topical
Labeler: Cosette Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210765
Marketing start: Aug 2, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)Vitamin D (Chemical structure)
Identifiers: Product ID 0713-0848_1f935790-9208-96ae-e063-6294a90ae07cSPL ID 1f935790-9208-96ae-e063-6294a90ae07cSPL set ID 1eba330b-ce18-6b12-e063-6294a90a8763RxCUI 833461UNII 826Y60901U, 143NQ3779B
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

N400713084860 followed by a unit qualifier and the quantity

Package 00713-0848-60. 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 Aug 13, 2024.

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 topic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210765

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210765
Product	Strength	Form · route	Labeler	Product NDC
Atterocalcipotriene and betamethasone dipropionate	Calcipotriene .05 mg/g; Betamethasone dipropionate .5 mg/g	SolutionTopical	Perfero Pharma, Inc.	87143-100