Prescription drug · ANDA
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% NDC 21922-016
clobetasol propionate cream usp, 0.05% · Clobetasol propionate .5 mg/g · Cream · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-016-04 | 21922001604 | 15 g in 1 TUBE (21922-016-04)Marketed from Oct 1, 2020 | |
| 21922-016-05 | 21922001605 | 30 g in 1 TUBE (21922-016-05)Marketed from Oct 1, 2020 | |
| 21922-016-06 | 21922001606 | 45 g in 1 TUBE (21922-016-06)Marketed from Oct 1, 2020 | |
| 21922-016-07 | 21922001607 | 60 g in 1 TUBE (21922-016-07)Marketed from Oct 1, 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)
- Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%Suffix: Clobetasol Propionate Cream USP, 0.05%
- Generic name (nonproprietary)
- clobetasol propionate cream usp, 0.05%
- Active ingredients
- Clobetasol propionate — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212982
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 21922-016_9c24c432-e7c9-4992-9f80-76378d43dd46SPL ID 9c24c432-e7c9-4992-9f80-76378d43dd46SPL set ID bcb76b4b-194d-4cb3-b3ed-26b911df1a11RxCUI 861495UNII 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
N421922001604followed by a unit qualifier and the quantityPackage 21922-0016-04. 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)
INDICATIONS AND USAGE: Clobetasol propionate cream USP, 0.05% is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g /week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212982
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 Cream, 0.05% Clobetasol Propionate Cream, 0.05%clobetasol propionate cream, 0.05% | Clobetasol propionate .5 mg/g | CreamTopical | Proficient Rx LP | 82804-133 |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%clobetasol propionate usp, 0.05% | Clobetasol propionate .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-5979 |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%clobetasol propionate cream usp, 0.05% | Clobetasol propionate .5 mg/g | CreamTopical | Northstar Rx LLC | 72603-323 |
| Clobetasol Propionate Cream 0.05% Clobetasol Propionate Cream 0.05%clobetasol propionate cream 0.05% | Clobetasol propionate .5 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-4001 |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%clobetasol propionate cream usp, 0.05% | Clobetasol propionate .5 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-2300 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | DIRECT RX | 72189-262 |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%clobetasol propionate usp, 0.05% | Clobetasol propionate .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-7392 |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%clobetasol propionate cream usp, 0.05% | Clobetasol propionate .5 mg/g | CreamTopical | REMEDYREPACK INC. | 70518-4374 |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%clobetasol propionate cream usp, 0.05% | Clobetasol propionate .5 mg/g | CreamTopical | Bryant Ranch Prepack | 71335-2821 |