Prescription drug · ANDA
Clobetasol Propionate NDC 45802-437
Clobetasol propionate .5 mg/g · Aerosol, Foam · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-437-32 | 4580204373245802043732 | 1 CAN in 1 CARTON (45802-437-32) / 50 g in 1 CANMarketed from Mar 20, 2008 | |
| 45802-437-33 | 4580204373345802043733 | 1 CAN in 1 CARTON (45802-437-33) / 100 g in 1 CANMarketed from Mar 20, 2008 |
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)
- Clobetasol Propionate
- Generic name (nonproprietary)
- clobetasol propionate
- Active ingredients
- Clobetasol propionate — .5 mg/g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077763
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 45802-437_b6daaa57-be91-4dc3-9cc4-aeb6402241ecSPL ID b6daaa57-be91-4dc3-9cc4-aeb6402241ecSPL set ID 3f75880b-9ead-4c6e-b999-3bd7e1643ce5RxCUI 861353UNII 779619577M
- Pharmacologic class
- Corticosteroid
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
N445802043732followed by a unit qualifier and the quantityPackage 45802-0437-32. 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)
Clobetasol Propionate Foam, 0.05% is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. Clobetasol Propionate Foam, 0.05% is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 45802-437
- What is NDC 45802-437?
- 45802-437 is the product NDC for Clobetasol Propionate, Clobetasol propionate .5 mg/g aerosol, foam, 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?
- Clobetasol Propionate.
- What is the active ingredient?
- Clobetasol propionate.
- 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 Clobetasol Propionate?
- 96 other product NDCs are listed under this name. See all Clobetasol Propionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clobetasol Propionate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | OintmentTopical | A-S Medication Solutions | 50090-8001 | 50090-8001-00 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | OintmentTopical | NorthStar RxLLC | 72603-855 | 72603-0855-0172603-0855-0272603-0855-03+1 more |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | Aerosol, FoamTopical | Alembic Pharmaceuticals Limited | 46708-707 | 46708-0707-3146708-0707-50 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | Alembic Pharmaceuticals Limited | 46708-547 | 46708-0547-1546708-0547-3046708-0547-45+1 more |
| Clobetasol Propionate | Clobetasol propionate .05 g/100mL | ShampooTopical | Alembic Pharmaceuticals Limited | 46708-548 | 46708-0548-04 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/mL | SolutionTopical | Alembic Pharmaceuticals Limited | 46708-486 | 46708-0486-2546708-0486-50 |
| Clobetasol Propionate | Clobetasol propionate .05 g/mL | SprayTopical | Alembic Pharmaceuticals Limited | 46708-425 | 46708-0425-1246708-0425-59 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | OintmentTopical | Alembic Pharmaceuticals Limited | 46708-465 | 46708-0465-1546708-0465-3046708-0465-45+1 more |
| Clobetasol Propionate | Clobetasol propionate .25 mg/g | CreamTopical | INA Pharmaceutics Inc | 74157-710 | 74157-0710-10 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | Torrent Pharmaceuticals Limited | 13668-569 | 13668-0569-0113668-0569-0213668-0569-04+1 more |
Other NDCs under ANDA 077763
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 |
|---|---|---|---|---|
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | Aerosol, FoamTopical | Bryant Ranch Prepack | 63629-9460 |