NDC codes

FDA NDC Directory
Product NDC (as listed)0037-6822Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00037-6822Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0037-6822-1000037682210000376822101 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

N400037682210 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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