What is NDC 0713-0631?

0713-0631 is the product NDC for Fluticasone Propionate, Fluticasone propionate .5 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 Fluticasone Propionate?

62 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluticasone Propionate NDC 0713-0631 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0631Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0631Add 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
0713-0631-15	00713063115	1 TUBE in 1 CARTON (0713-0631-15) / 15 g in 1 TUBEMarketed from Jun 30, 2006
0713-0631-31	00713063131	1 TUBE in 1 CARTON (0713-0631-31) / 30 g in 1 TUBEMarketed from Jun 30, 2006
0713-0631-60	00713063160	1 TUBE in 1 CARTON (0713-0631-60) / 60 g in 1 TUBEMarketed from Jun 30, 2006

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): Fluticasone Propionate
Generic name (nonproprietary): fluticasone propionate
Active ingredients: Fluticasone propionate — .5 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 077055
Marketing start: Jun 30, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0713-0631_de485a69-2992-143b-e053-2a95a90a4b89SPL ID de485a69-2992-143b-e053-2a95a90a4b89SPL set ID 14c8d082-b301-8f09-a509-950459ae0a28RxCUI 895987UNII O2GMZ0LF5WUPC 0307130631150, 0307130631310, 0307130631600
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

N400713063115 followed by a unit qualifier and the quantity

Package 00713-0631-15. 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 May 5, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluticasone Propionate Cream, USP 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone Propionate Cream, USP 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of Fluticasone Propionate Cream, USP 0.05% in pediatric patients below 3 months of age have not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0631

What is NDC 0713-0631?: 0713-0631 is the product NDC for Fluticasone Propionate, Fluticasone propionate .5 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?: Fluticasone Propionate.
What is the active ingredient?: Fluticasone propionate.
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 Fluticasone Propionate?: 62 other product NDCs are listed under this name. See all Fluticasone Propionate 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 Fluticasone Propionate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fluticasone Propionate	Fluticasone propionate 50 ug/1	Spray, MeteredNasal	YYBA Corp	73581-510	73581-0510-0173581-0510-03
Fluticasone Propionate	Fluticasone propionate 50 ug/1	Spray, MeteredNasal	Glenmark Pharmaceuticals Inc., USA	68462-918	68462-0918-2068462-0918-4468462-0918-60+1 more
Fluticasone Propionate	Fluticasone propionate 50 ug/1	Spray, MeteredNasal	P & L Development, LLC	59726-350	59726-0350-3859726-0350-54
Fluticasone Propionate	Fluticasone propionate 50 ug/1	Spray, MeteredNasal	Chain Drug Marketing Association, Inc.	83324-294	83324-0294-01
Fluticasone Propionate	Fluticasone propionate 50 ug/1	Spray, MeteredNasal	Family Dollar Stores, LLC	55319-058	55319-0058-01
Fluticasone Propionate	Fluticasone propionate 50 ug/1	SprayNasal	Preferred Pharmaceuticals Inc.	68788-4120	68788-4120-01
Fluticasone Propionate	Fluticasone propionate 50 ug/1	Spray, MeteredNasal	Allegiant Health	69168-014	69168-0014-01
Fluticasone Propionate	Fluticasone propionate 44 ug/1	Aerosol, MeteredRespiratory (Inhalation)	Glenmark Pharmaceuticals Inc., USA	68462-937	68462-0937-20
Fluticasone Propionate	Fluticasone propionate 50 ug/1	Spray, MeteredNasal	Grocery Outlet	85828-448	85828-0448-01
Fluticasone Propionate	Fluticasone propionate 50 ug/1	Spray, MeteredNasal	IPG Pharmaceuticals, Inc.	71085-090	71085-0090-1671085-0090-32

All 63 Fluticasone Propionate NDCs