Prescription drug · ANDA
Calcipotriene and Betamethasone Dipropionate NDC 45802-816
calcipotriene, betamethasone dipropionate · Calcipotriene 50 ug/g; Betamethasone dipropionate .643 mg/g · Ointment · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-816-01 | 4580208160145802081601 | 1 TUBE in 1 CARTON (45802-816-01) / 100 g in 1 TUBEMarketed from Jan 30, 2020 | |
| 45802-816-96 | 4580208169645802081696 | 1 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBEMarketed from Jan 30, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, betamethasone dipropionate
- Active ingredients
- Calcipotriene — 50 ug/gBetamethasone dipropionate — .643 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200174
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Vitamin D (Chemical structure)
- Identifiers
- Product ID 45802-816_9b7de25a-99a2-4123-b913-ba33289ff5beSPL ID 9b7de25a-99a2-4123-b913-ba33289ff5beSPL set ID ba55ff2b-9cfe-40dc-9dac-718cf141c171RxCUI 388525UNII 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
N445802081601followed by a unit qualifier and the quantityPackage 45802-0816-01. 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 Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. Calcipotriene and Betamethasone Dipropionate Ointment is a vitamin D analogue and corticosteroid combination product indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 45802-816
- What is NDC 45802-816?
- 45802-816 is the product NDC for Calcipotriene and Betamethasone Dipropionate, Calcipotriene 50 ug/g; Betamethasone dipropionate .643 mg/g ointment, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calcipotriene and Betamethasone Dipropionate (Calcipotriene, Betamethasone Dipropionate).
- What is the active ingredient?
- Calcipotriene, Betamethasone dipropionate.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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 Dipropionate | Calcipotriene 50 ug/g; Betamethasone dipropionate 50 mg/g | SuspensionTopical | Sun Pharmaceutical Industries, Inc. | 51672-1402 | 51672-1402-0451672-1402-08 |
| 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 |
Other NDCs under ANDA 200174
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 and Betamethasone Dipropionatecalcipotriene, betamethasone dipropionate | Calcipotriene 50 ug/g; Betamethasone dipropionate .643 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-2520 |
| Calcipotriene and Betamethasone Dipropionatecalcipotriene, betamethasone dipropionate | Calcipotriene 50 ug/g; Betamethasone dipropionate .643 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-8617 |
| Calcipotriene and Betamethasone Dipropionatecalcipotriene, betamethasone dipropionate | Calcipotriene 50 ug/g; Betamethasone dipropionate .643 mg/g | OintmentTopical | Bryant Ranch Prepack | 72162-1428 |