NDC codes

FDA NDC Directory
Product NDC (as listed)72189-518Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0518Add 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
72189-518-15721890518157218905181515 g in 1 TUBE (72189-518-15)Marketed from Oct 25, 2023

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)
Clotrimazole/Betameth
Generic name (nonproprietary)
clotrimazole/betameth
Active ingredients
Betamethasone dipropionate — .5 mg/gClotrimazole — 10 mg/g
Dosage form
Cream
Route
Topical
Labeler
Direct_RxNDC labeler code 72189
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076002
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 72189-518_4d3aa580-669c-dddb-e063-6294a90a1152SPL ID 4d3aa580-669c-dddb-e063-6294a90a1152SPL set ID 08901233-7d36-e5d9-e063-6394a90af33dRxCUI 308714UNII 826Y60901U, G07GZ97H65
Pharmacologic class
Azole Antifungal; 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

N472189051815 followed by a unit qualifier and the quantity

Package 72189-0518-15. 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)

Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-518

What is NDC 72189-518?
72189-518 is the product NDC for Clotrimazole/Betameth, Betamethasone dipropionate .5 mg/g; Clotrimazole 10 mg/g cream, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clotrimazole/Betameth.
What is the active ingredient?
Betamethasone dipropionate, Clotrimazole.
Who is the labeler?
Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clotrimazole/Betameth?
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 076002

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076002
ProductStrengthForm · routeLabelerProduct NDC
Clotrimazole and Betamethasone DipropionateClotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/gCreamTopicalActavis Pharma, Inc.0472-0379
Clotrimazole and Betamethasone DipropionateClotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/gCreamTopicalA-S Medication Solutions50090-0741
Clotrimazole and Betamethasone DipropionateClotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/gCreamTopicalProficient Rx LP63187-095
Clotrimazole and Betamethasone DipropionateClotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/gCreamTopicalBryant Ranch Prepack63629-8758

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