Prescription drug · ANDA
Clobetasol Propionate NDC 62332-425
Clobetasol propionate .05 g/mL · Spray · Topical · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-425-12 | 62332042512 | 1 BOTTLE in 1 CARTON (62332-425-12) / 125 mL in 1 BOTTLEMarketed from Nov 30, 2020 | |
| 62332-425-59 | 62332042559 | 1 BOTTLE in 1 CARTON (62332-425-59) / 59 mL in 1 BOTTLEMarketed from Nov 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/mL
- Dosage form
- Spray
- Route
- Topical
- Labeler
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211191
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 62332-425_6c5ef90d-a66f-4b40-a813-ae836e38ac97SPL ID 6c5ef90d-a66f-4b40-a813-ae836e38ac97SPL set ID a83d212b-a970-4ee7-8431-fead6b2e7f9dRxCUI 861512UNII 779619577MUPC 0362332425594, 0362332425129
- 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
N462332042512followed by a unit qualifier and the quantityPackage 62332-0425-12. 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 topical spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) 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 topical spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Patients should be ins…
Excerpt only. Read the full label for complete information.
About NDC 62332-425
- What is NDC 62332-425?
- 62332-425 is the product NDC for Clobetasol Propionate, Clobetasol propionate .05 g/mL spray, listed with the FDA by Alembic 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?
- Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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?
- 102 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 211191
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/mL | SprayTopical | Alembic Pharmaceuticals Limited | 46708-425 |