Prescription drug · ANDA
Proctofoam Hc NDC 0037-6822
pramoxine hydrochloride hydrocortisone acetate · Pramoxine hydrochloride 100 mg/10g; Hydrocortisone acetate 100 mg/10g · Aerosol, Foam · Topical · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0037-6822-10 | 0003768221000037682210 | 1 CANISTER in 1 CARTON (0037-6822-10) / 10 g in 1 CANISTERMarketed from Aug 15, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Proctofoam HcSuffix: HC
- Generic name (nonproprietary)
- pramoxine hydrochloride hydrocortisone acetate
- Active ingredients
- Pramoxine hydrochloride — 100 mg/10gHydrocortisone acetate — 100 mg/10g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Labeler
- Viatris Specialty LLCNDC labeler code 0037
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086195
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0037-6822_d63033a1-dca0-44f9-a6f3-210e38c2691eSPL ID d63033a1-dca0-44f9-a6f3-210e38c2691eSPL set ID 3831e931-ec0a-11e3-ac10-0800200c9a66RxCUI 828362, 828364UNII 88AYB867L5, 3X7931PO74
- 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
N400037682210followed by a unit qualifier and the quantityPackage 00037-6822-10. 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)
INDICATIONS AND USAGE Proctofoam ® HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.
Excerpt only. Read the full label for complete information.
About NDC 0037-6822
- What is NDC 0037-6822?
- 0037-6822 is the product NDC for Proctofoam Hc, Pramoxine hydrochloride 100 mg/10g; Hydrocortisone acetate 100 mg/10g aerosol, foam, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Proctofoam Hc (Pramoxine hydrochloride hydrocortisone acetate).
- What is the active ingredient?
- Pramoxine hydrochloride, Hydrocortisone acetate.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 0037. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Proctofoam Hc?
- 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.