Prescription drug · ANDA
Clobetasol Propionate Cream, 0.05% Clobetasol Propionate Cream, 0.05% (Clobetasol propionate cream, 0.05%) NDC 82804-133
Clobetasol propionate .5 mg/g · Cream · Topical · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-133-30 | 8280401333082804013330 | 30 g in 1 TUBE (82804-133-30)Marketed from Aug 7, 2024 |
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, 0.05% Clobetasol Propionate Cream, 0.05%Suffix: Clobetasol Propionate Cream, 0.05%
- Generic name (nonproprietary)
- clobetasol propionate cream, 0.05%
- Active ingredients
- Clobetasol propionate — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-133_6f52ac0f-4028-4733-9ef6-e5ce5468b384SPL ID 6f52ac0f-4028-4733-9ef6-e5ce5468b384SPL set ID 6f52ac0f-4028-4733-9ef6-e5ce5468b384RxCUI 861495UNII 779619577MUPC 0382804133307
- 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
N482804013330followed by a unit qualifier and the quantityPackage 82804-0133-30. 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.
About NDC 82804-133
- What is NDC 82804-133?
- 82804-133 is the product NDC for Clobetasol Propionate Cream, 0.05% Clobetasol Propionate Cream, 0.05%, Clobetasol propionate .5 mg/g cream, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clobetasol Propionate Cream, 0.05% Clobetasol Propionate Cream, 0.05% (Clobetasol Propionate Cream, 0.05%).
- What is the active ingredient?
- Clobetasol propionate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. 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 Cream, 0.05% Clobetasol Propionate Cream, 0.05%?
- 1 other product NDC are listed under this name. See all Clobetasol Propionate Cream, 0.05% Clobetasol Propionate Cream, 0.05% 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 Cream, 0.05% Clobetasol Propionate Cream, 0.05% 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 Cream 0.05% Clobetasol Propionate Cream 0.05%clobetasol propionate cream 0.05% | Clobetasol propionate .5 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-4001 | 68788-4001-06 |
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 | Clobetasol propionate .5 mg/g | CreamTopical | DIRECT RX | 72189-262 |
| 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 | Encube Ethicals, Inc. | 21922-016 |
| 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 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 |
| 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 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 |