NDC codes

FDA NDC Directory
Product NDC (as listed)51672-1303Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-1303Add 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
51672-1303-151672130301516721303011 TUBE in 1 CARTON (51672-1303-1) / 15 g in 1 TUBEMarketed from Nov 26, 2002
51672-1303-251672130302516721303021 TUBE in 1 CARTON (51672-1303-2) / 30 g in 1 TUBEMarketed from Nov 26, 2002
51672-1303-851672130308516721303081 TUBE in 1 CARTON (51672-1303-8) / 85 g in 1 TUBEMarketed from Nov 26, 2002

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)
Econazole Nitrate
Generic name (nonproprietary)
econazole nitrate
Active ingredients
Econazole nitrate — 10 mg/g
Dosage form
Cream
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 076005
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 51672-1303_3d47799f-26f4-68d6-e063-6294a90a4ab5SPL ID 3d47799f-26f4-68d6-e063-6294a90a4ab5SPL set ID 90c40d7f-94fa-440c-9815-30378f76ae79RxCUI 857366UNII H438WYN10EUPC 0351672130312
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

N451672130301 followed by a unit qualifier and the quantity

Package 51672-1303-01. 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 Econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51672-1303

What is NDC 51672-1303?
51672-1303 is the product NDC for Econazole Nitrate, Econazole nitrate 10 mg/g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Econazole Nitrate.
What is the active ingredient?
Econazole nitrate.
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 Econazole Nitrate?
11 other product NDCs are listed under this name. See all Econazole Nitrate 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 Econazole Nitrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Econazole NitrateEconazole nitrate 10 mg/gCreamTopicalEncube Ethicals, Inc.21922-11121922-0111-0421922-0111-0521922-0111-15
Econazole NitrateEconazole nitrate 10 mg/gCreamTopicalAurobindo Pharma Limited59651-94559651-0945-1459651-0945-3059651-0945-85
Econazole NitrateEconazole nitrate 10 mg/gAerosol, FoamTopicalTrifluent Pharma, LLC73352-10073352-0100-70
Econazole NitrateEconazole nitrate 10 mg/gCreamTopicalPreferred Pharmaceuticals Inc.68788-817468788-8174-01
Econazole NitrateEconazole nitrate 10 mg/gCreamTopicalPreferred Pharmaceuticals Inc.68788-817068788-8170-03
Econazole NitrateEconazole nitrate 10 mg/gCreamTopicalPadagis Israel Pharmaceuticals Ltd45802-46645802-0466-1145802-0466-3545802-0466-53
Econazole NitrateEconazole nitrate 10 mg/gCreamTopicalBryant Ranch Prepack63629-864563629-8645-01
Econazole NitrateEconazole nitrate 10 mg/gCreamTopicalBryant Ranch Prepack63629-864663629-8646-01
Econazole NitrateEconazole nitrate 10 mg/gCreamTopicalBryant Ranch Prepack63629-864763629-8647-01
Econazole NitrateEconazole nitrate 10 mg/gCreamTopicalPreferred Pharmaceuticals Inc.68788-888468788-8884-03

All 12 Econazole Nitrate NDCs

Other NDCs under ANDA 076005

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

FDA NDC Directory listings under ANDA 076005
ProductStrengthForm · routeLabelerProduct NDC
Econazole NitrateEconazole nitrate 10 mg/gCreamTopicalPreferred Pharmaceuticals Inc.68788-8174

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