Nitroglycerin NDC 0378-9116

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-9116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-9116Add 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
0378-9116-93	00378911693	30 POUCH in 1 CARTON (0378-9116-93) / 1 PATCH in 1 POUCH (0378-9116-16) / 14 h in 1 PATCHMarketed from Aug 30, 1996

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 — .6 mg/h
Dosage form: Patch
Route: Transdermal
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074559
Marketing start: Aug 30, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 0378-9116_68d53366-0e2b-4370-a084-af17a1a88681SPL ID 68d53366-0e2b-4370-a084-af17a1a88681SPL set ID e98a2692-1cb9-4994-98d8-1d8d9ef1a256RxCUI 486146, 486148, 486152, 861657UNII G59M7S0WS3
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 HCPCS code in Med-Code's directory. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378911693 followed by a unit qualifier and the quantity

Package 00378-9116-93. 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 3, 2014.

Indications (excerpt from the label)

INDICATIONS AND USAGE Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074559

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

FDA NDC Directory listings under ANDA 074559
Product	Strength	Form · route	Labeler	Product NDC
Nitroglycerin	Nitroglycerin .1 mg/h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-9102
Nitroglycerin	Nitroglycerin .2 mg/h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-9104
Nitroglycerin	Nitroglycerin .4 mg/h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-9112