Prescription drug · ANDA
Clobetasol Propionate NDC 72578-085
Clobetasol propionate .05 g/100mL · Lotion · Topical · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-085-01 | 7257800850172578008501 | 1 BOTTLE in 1 CARTON (72578-085-01) / 59 mL in 1 BOTTLEMarketed from Apr 30, 2020 | |
| 72578-085-02 | 7257800850272578008502 | 1 BOTTLE in 1 CARTON (72578-085-02) / 118 mL in 1 BOTTLEMarketed from Apr 30, 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
- Generic name (nonproprietary)
- clobetasol propionate
- Active ingredients
- Clobetasol propionate — .05 g/100mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Viona Pharmaceuticals IncNDC labeler code 72578
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205249
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72578-085_7885e4e8-e37e-4eaf-b632-f09f28f825cfSPL ID 7885e4e8-e37e-4eaf-b632-f09f28f825cfSPL set ID 2fc7de5f-094f-400c-b87e-750b16046f46RxCUI 861505UNII 779619577MUPC 0372578085018
- 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
N472578008501followed by a unit qualifier and the quantityPackage 72578-0085-01. 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 lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older ( 1.1 ). Limitations of Use: Do not use on the face, axillae or groin. ( 1.2 ) Do not use if atrophy is present at the treatment site. ( 1.2 ) Do not use for rosacea or perioral dermatitis. ( 1.2 ) 1.1 Indication Clobetasol propionate lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. Treatment should be limited to…
Excerpt only. Read the full label for complete information.
About NDC 72578-085
- What is NDC 72578-085?
- 72578-085 is the product NDC for Clobetasol Propionate, Clobetasol propionate .05 g/100mL lotion, listed with the FDA by Viona Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clobetasol Propionate.
- What is the active ingredient?
- Clobetasol propionate.
- Who is the labeler?
- Viona Pharmaceuticals Inc, NDC labeler code 72578. 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?
- 96 other product NDCs are listed under this name. See all Clobetasol Propionate 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 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 | Clobetasol propionate .5 mg/g | OintmentTopical | A-S Medication Solutions | 50090-8001 | 50090-8001-00 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | OintmentTopical | NorthStar RxLLC | 72603-855 | 72603-0855-0172603-0855-0272603-0855-03+1 more |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | Aerosol, FoamTopical | Alembic Pharmaceuticals Limited | 46708-707 | 46708-0707-3146708-0707-50 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | Alembic Pharmaceuticals Limited | 46708-547 | 46708-0547-1546708-0547-3046708-0547-45+1 more |
| Clobetasol Propionate | Clobetasol propionate .05 g/100mL | ShampooTopical | Alembic Pharmaceuticals Limited | 46708-548 | 46708-0548-04 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/mL | SolutionTopical | Alembic Pharmaceuticals Limited | 46708-486 | 46708-0486-2546708-0486-50 |
| Clobetasol Propionate | Clobetasol propionate .05 g/mL | SprayTopical | Alembic Pharmaceuticals Limited | 46708-425 | 46708-0425-1246708-0425-59 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | OintmentTopical | Alembic Pharmaceuticals Limited | 46708-465 | 46708-0465-1546708-0465-3046708-0465-45+1 more |
| Clobetasol Propionate | Clobetasol propionate .25 mg/g | CreamTopical | INA Pharmaceutics Inc | 74157-710 | 74157-0710-10 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | Torrent Pharmaceuticals Limited | 13668-569 | 13668-0569-0113668-0569-0213668-0569-04+1 more |
Other NDCs under ANDA 205249
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 | LotionTopical | Zydus Lifesciences Limited | 70771-1498 |