NDC codes

FDA NDC Directory
Product NDC (as listed)51672-1260Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-1260Add 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
51672-1260-351672126003516721260031 BOTTLE, PLASTIC in 1 CARTON (51672-1260-3) / 30 mL in 1 BOTTLE, PLASTICMarketed from Jul 29, 1996

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Generic name (nonproprietary)
clotrimazole
Active ingredients
Clotrimazole — 10 mg/mL
Dosage form
Solution
Route
Topical
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074580
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 51672-1260_390848b9-e9c6-c3c4-e063-6294a90a5b26SPL ID 390848b9-e9c6-c3c4-e063-6294a90a5b26SPL set ID 3e2041a0-8bef-4be4-b2b1-556446c4a778RxCUI 309370UNII G07GZ97H65
Pharmacologic class
Azole Antifungal

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

N451672126003 followed by a unit qualifier and the quantity

Package 51672-1260-03. 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 Prescription CLOTRIMAZOLE TOPICAL SOLUTION product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton fluoccosum , and Microsporum canis .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51672-1260

What is NDC 51672-1260?
51672-1260 is the product NDC for Clotrimazole, Clotrimazole 10 mg/mL solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clotrimazole.
What is the active ingredient?
Clotrimazole.
Who is the labeler?
Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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?
63 other product NDCs are listed under this name. See all Clotrimazole NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Clotrimazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ClotrimazoleClotrimazole 1 g/mLSolutionTopicalInvaDerm Corporation71457-52371457-0523-1071457-0523-30
ClotrimazoleClotrimazole 1 g/mLSolutionTopicalYYBA CORP73581-44873581-0448-30
ClotrimazoleClotrimazole 1 g/100gCreamVaginalYYBA CORP73581-45073581-0450-01
ClotrimazoleClotrimazole 100 kg/100kgGranuleTopicalShaanxi Shuvita Biotech Co., Ltd87879-00187879-0001-01
ClotrimazoleClotrimazole 10 mg/mLSolutionTopicalPreferred Pharmaceuticals Inc.68788-415568788-4155-03
ClotrimazoleClotrimazole 1 g/mLSolutionTopicalPreferred Pharmaceuticals Inc.68788-408068788-4080-01
ClotrimazoleClotrimazole 1 g/mLSolutionTopicalAvPAK50268-04450268-0044-30
ClotrimazoleClotrimazole 10 mg/gCreamVaginalCardinal Health (Leader) 7000070000-072970000-0729-01
ClotrimazoleClotrimazole 1 g/100gCreamTopicalPreferred Pharmaceuticals Inc.68788-883068788-8830-02
ClotrimazoleClotrimazole 1 g/100mLSolutionTopicalRugby Laboratories, Inc.0536-144300536-1443-70

All 64 Clotrimazole NDCs

Other NDCs under ANDA 074580

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

FDA NDC Directory listings under ANDA 074580
ProductStrengthForm · routeLabelerProduct NDC
ClotrimazoleClotrimazole 10 mg/mLSolutionTopicalPreferred Pharmaceuticals Inc.68788-4155

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in