Prescription drug · ANDA
Clobetasol Propionate (emollient) (Clobetasol propionate) NDC 83148-064
Clobetasol propionate .5 mg/g · Cream · Topical · The J. Molner Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83148-064-15 | 8314800641583148006415 | 1 TUBE in 1 CARTON (83148-064-15) / 15 g in 1 TUBEMarketed from Sep 29, 2025 | |
| 83148-064-30 | 8314800643083148006430 | 1 TUBE in 1 CARTON (83148-064-30) / 30 g in 1 TUBEMarketed from Oct 1, 2025 | |
| 83148-064-60 | 8314800646083148006460 | 1 TUBE in 1 CARTON (83148-064-60) / 60 g in 1 TUBEMarketed from Sep 29, 2025 |
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 (emollient)
- Generic name (nonproprietary)
- clobetasol propionate
- Active ingredients
- Clobetasol propionate — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- The J. Molner Company LLCNDC labeler code 83148
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209411
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 83148-064_40290b7e-9b7d-6810-e063-6394a90a2d5dSPL ID 40290b7e-9b7d-6810-e063-6394a90a2d5dSPL set ID 26ccb1d8-c466-e238-e063-6394a90a0069RxCUI 1992281UNII 779619577MUPC 0383148064159
- 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
N483148006415followed by a unit qualifier and the quantityPackage 83148-0064-15. 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 cream USP, 0.05% (emollient) is a corticosteroid indicated for: The relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. (1.1) The treatment of moderate to severe plaque-type psoriasis in patients 16 years of age and older. (1.2) Limitations of Use Clobetasol propionate cream USP, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. (1.3) The total dosage should not exceed 50 grams per week. (1.3) Avoid use if skin atrophy is present at the treatment site. (1.3) Clobetasol propionate cream USP, 0.05% (…
Excerpt only. Read the full label for complete information.
About NDC 83148-064
- What is NDC 83148-064?
- 83148-064 is the product NDC for Clobetasol Propionate (emollient), Clobetasol propionate .5 mg/g cream, listed with the FDA by The J. Molner Company LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clobetasol Propionate (emollient) (Clobetasol propionate).
- What is the active ingredient?
- Clobetasol propionate.
- Who is the labeler?
- The J. Molner Company LLC, NDC labeler code 83148. 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 (emollient)?
- 1 other product NDC are listed under this name. See all Clobetasol Propionate (emollient) 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 (emollient) 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 (emollient)clobetasol propionate | Clobetasol propionate .5 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-2628 | 72162-2628-0272162-2628-0372162-2628-06 |
Other NDCs under ANDA 209411
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 (emollient)clobetasol propionate | Clobetasol propionate .5 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-2628 |