Prescription drug · ANDA
clobetasol propionate NDC 45802-961
Clobetasol propionate .05 g/100mL · Shampoo · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-961-26 | 45802096126 | 118 mL in 1 BOTTLE (45802-961-26)Marketed from Aug 10, 2012 |
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 — .05 g/100mL
- Dosage form
- Shampoo
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090974
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 45802-961_2f67f66e-21f7-433a-917b-608bb4a5a317SPL ID 2f67f66e-21f7-433a-917b-608bb4a5a317SPL set ID 49bfff2e-9e4d-48a4-9f74-d6cf5b312acaRxCUI 861490UNII 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
N445802096126followed by a unit qualifier and the quantityPackage 45802-0961-26. 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 Shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older ( 1 ). Limitations of Use: • Do not use on the face, axillae or groin. ( 1.2 ) • Avoid any contact with the eyes and lips. ( 1.2 ) 1.1 Indication Clobetasol Propionate Shampoo, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week. Patients should be instructed to use Clobetasol Propionate…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090974
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 .05 g/100mL | ShampooTopical | Bryant Ranch Prepack | 72162-1442 |
| Clodanclobetasol propionate | Clobetasol propionate .5 mg/mL | ShampooTopical | Medimetriks Pharmaceuticals | 43538-950 |
| clobetasol propionate | Clobetasol propionate .05 g/100mL | ShampooTopical | Bryant Ranch Prepack | 63629-9461 |