What is NDC 0713-0564?

0713-0564 is the product NDC for Nitroglycerin, Nitroglycerin 4 mg/g ointment, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, 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 Nitroglycerin?

69 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nitroglycerin NDC 0713-0564 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0564Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0564Add 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	Copy
0713-0564-31	0071305643100713056431	1 TUBE in 1 CARTON (0713-0564-31) / 30 g in 1 TUBEMarketed from Feb 23, 2024

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): Nitroglycerin
Generic name (nonproprietary): nitroglycerin
Active ingredients: Nitroglycerin — 4 mg/g
Dosage form: Ointment
Route: Rectal
Labeler: Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216103
Marketing start: Feb 23, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 0713-0564_11e6d0dd-d89a-7551-e063-6394a90a16ceSPL ID 11e6d0dd-d89a-7551-e063-6394a90a16ceSPL set ID ac908e70-9425-4e9c-8c67-7b2882b40204RxCUI 1114466UNII G59M7S0WS3UPC 0307130564311
Pharmacologic class: Nitrate Vasodilator

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400713056431 followed by a unit qualifier and the quantity

Package 00713-0564-31. 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 Feb 21, 2024.

Indications (excerpt from the label)

Nitroglycerin ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure. Nitroglycerin ointment is a nitrate vasodilator indicated for the treatment of moderate to severe pain associated with chronic anal fissure ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0564

What is NDC 0713-0564?: 0713-0564 is the product NDC for Nitroglycerin, Nitroglycerin 4 mg/g ointment, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nitroglycerin.
What is the active ingredient?: Nitroglycerin.
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 Nitroglycerin?: 69 other product NDCs are listed under this name. See all Nitroglycerin 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 Nitroglycerin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nitroglycerin	Nitroglycerin 4 mg/g	OintmentRectal	Padagis Israel Pharmaceuticals Ltd	45802-932	45802-0932-94
Nitroglycerin	Nitroglycerin 4 mg/g	OintmentRectal	Bryant Ranch Prepack	72162-2643	72162-2643-03
Nitroglycerin	Nitroglycerin 4 mg/g	OintmentRectal	Solaris Pharma Corporation	73473-500	73473-0500-30
Nitroglycerin	Nitroglycerin .3 mg/1	TabletSublingual	Solco Healthcare U.S., LLC	43547-985	43547-0985-0443547-0985-10
Nitroglycerin	Nitroglycerin .4 mg/1	TabletSublingual	Solco Healthcare U.S., LLC	43547-986	43547-0986-0443547-0986-10
Nitroglycerin	Nitroglycerin .6 mg/1	TabletSublingual	Solco Healthcare U.S., LLC	43547-987	43547-0987-0443547-0987-10
Nitroglycerin	Nitroglycerin 20 mg/g	OintmentTopical	Encube Ethicals, Inc.	21922-054	21922-0054-0521922-0054-47
nitroglycerin	Nitroglycerin .4 mg/1	TabletSublingual	REMEDYREPACK INC.	70518-4277	70518-4277-0070518-4277-01
Nitroglycerin	Nitroglycerin 4 mg/g	OintmentRectal	Encube Ethicals, Inc.	21922-048	21922-0048-05
Nitroglycerin	Nitroglycerin 400 ug/1	SprayOral	HF Acquisition Co LLC, DBA HealthFirst	51662-1672	51662-1672-01

All 70 Nitroglycerin NDCs