Prescription drug · ANDA
Clobetasol Propionate NDC 16714-030
Clobetasol propionate .05 g/100mL · Shampoo · Topical · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-030-01 | 16714003001 | 1 BOTTLE in 1 CARTON (16714-030-01) / 118 mL in 1 BOTTLEMarketed from Mar 28, 2021 |
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
- Labeler
- NORTHSTAR RX LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214867
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 16714-030_397f7f23-ec6b-7cc4-e063-6294a90aab0bSPL ID 397f7f23-ec6b-7cc4-e063-6294a90aab0bSPL set ID 72c90da7-5f6a-4b8d-875d-f07ceeec295eRxCUI 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
N416714003001followed by a unit qualifier and the quantityPackage 16714-0030-01. 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)
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 sh…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214867
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 | Sun Pharmaceutical Industries, Inc. | 51672-1347 |