What is NDC 0713-0638?

0713-0638 is the product NDC for Ciclopirox Olamine, Ciclopirox olamine 7.7 mg/g cream, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ciclopirox Olamine?

15 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ciclopirox Olamine NDC 0713-0638 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0638Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0638Add 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 NDC	11-digit (billing)	Package
0713-0638-15	0071306381500713063815	1 TUBE in 1 BOX (0713-0638-15) / 15 g in 1 TUBEMarketed from May 22, 2007
0713-0638-18	0071306381800713063818	1 TUBE in 1 BOX (0713-0638-18) / 90 g in 1 TUBEMarketed from May 22, 2007
0713-0638-31	0071306383100713063831	1 TUBE in 1 BOX (0713-0638-31) / 30 g in 1 TUBEMarketed from May 22, 2007

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): Ciclopirox Olamine
Generic name (nonproprietary): ciclopirox olamine
Active ingredients: Ciclopirox olamine — 7.7 mg/g
Dosage form: Cream
Route: Topical
Labeler: Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078463
Marketing start: May 22, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Decreased DNA Replication (Physiologic effect)Decreased Protein Synthesis (Physiologic effect)Decreased RNA Replication (Physiologic effect)Protein Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 0713-0638_ed9669ad-fa01-5788-e053-2995a90a5897SPL ID ed9669ad-fa01-5788-e053-2995a90a5897SPL set ID 5c585aa5-7d2d-e798-c0bd-d602574d643cRxCUI 309289UNII 50MD4SB4APUPC 0307130638159

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

N400713063815 followed by a unit qualifier and the quantity

Package 00713-0638-15. 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 Nov 16, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ciclopirox Olamine Cream USP, 0.77% 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 floccosum , and Microsporum canis ; candidiasis (moniliasis) due to Candida albicans ; and tinea (pityriasis) versicolor due to Malassezia furfur .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0638

What is NDC 0713-0638?: 0713-0638 is the product NDC for Ciclopirox Olamine, Ciclopirox olamine 7.7 mg/g cream, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ciclopirox Olamine.
What is the active ingredient?: Ciclopirox olamine.
Who is the labeler?: Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ciclopirox Olamine?: 15 other product NDCs are listed under this name. See all Ciclopirox Olamine 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 Ciclopirox Olamine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ciclopirox Olamine	Ciclopirox olamine 7.7 mg/g	CreamTopical	Advanced Rx Pharmacy of Tennessee, LLC	80425-0225	80425-0225-01
Ciclopirox Olamine	Ciclopirox olamine 7.7 mg/g	CreamTopical	Glenmark Pharmaceuticals Inc., USA	68462-297	68462-0297-1768462-0297-3568462-0297-92
Ciclopirox Olamine	Ciclopirox olamine 7.7 mg/mL	SuspensionTopical	Padagis Israel Pharmaceuticals Ltd	45802-400	45802-0400-4645802-0400-49
Ciclopirox Olamine	Ciclopirox olamine 7.7 mg/100mL	SuspensionTopical	Bryant Ranch Prepack	63629-2522	63629-2522-01
Ciclopirox Olamine	Ciclopirox olamine 7.7 mg/100mL	SuspensionTopical	Bryant Ranch Prepack	63629-8627	63629-8627-01
Ciclopirox Olamine	Ciclopirox olamine 7.7 mg/100mL	SuspensionTopical	Bryant Ranch Prepack	71335-2717	71335-2717-01
Ciclopirox Olamine	Ciclopirox olamine 7.7 mg/100mL	SuspensionTopical	Bryant Ranch Prepack	71335-2915	71335-2915-01
Ciclopirox Olamine	Ciclopirox olamine 7.7 mg/100mL	SuspensionTopical	Bryant Ranch Prepack	72162-1406	72162-1406-0372162-1406-06
Ciclopirox olamine	Ciclopirox olamine 7.7 mg/g	CreamTopical	Padagis Israel Pharmaceuticals Ltd	45802-138	45802-0138-1145802-0138-1845802-0138-35
Ciclopirox Olamine	Ciclopirox olamine 7.7 mg/g	CreamTopical	Bryant Ranch Prepack	63629-8624	63629-8624-01

All 16 Ciclopirox Olamine NDCs