Prescription drug · ANDA
Tovet (emollient formulation) (Clobetasol propionate) NDC 43538-952
Clobetasol propionate .5 mg/g · Aerosol, Foam · Topical · Medimetriks Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43538-952-10 | 4353809521043538095210 | 1 CANISTER in 1 CARTON (43538-952-10) / 100 g in 1 CANISTERMarketed from Jul 31, 2019 |
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)
- Tovet (emollient formulation)
- Generic name (nonproprietary)
- clobetasol propionate
- Active ingredients
- Clobetasol propionate — .5 mg/g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Labeler
- Medimetriks Pharmaceuticals, Inc.NDC labeler code 43538
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201402
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43538-952_b29a088c-5b21-43bc-946f-29083835ce4eSPL ID b29a088c-5b21-43bc-946f-29083835ce4eSPL set ID 4d5c5b14-9e4f-4d43-a336-e4ae71d34e42RxCUI 1992273, 2180345UNII 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
N443538095210followed by a unit qualifier and the quantityPackage 43538-0952-10. 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)
Tovet Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. Tovet Foam is a corticosteroid indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 43538-952
- What is NDC 43538-952?
- 43538-952 is the product NDC for Tovet (emollient formulation) (clobetasol propionate), Clobetasol propionate .5 mg/g aerosol, foam, listed with the FDA by Medimetriks Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tovet (emollient formulation) (Clobetasol propionate).
- What is the active ingredient?
- Clobetasol propionate.
- Who is the labeler?
- Medimetriks Pharmaceuticals, Inc., NDC labeler code 43538. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tovet (emollient formulation)?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 201402
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 formulationclobetasol propionate | Clobetasol propionate .5 mg/g | Aerosol, FoamTopical | Padagis Israel Pharmaceuticals Ltd | 45802-637 |