Prescription drug · NDA
Nitro-Dur (Nitroglycerin) NDC 50742-515
Nitroglycerin 60 mg/1 · Patch · Transdermal · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-515-30 | 5074205153050742051530 | 30 POUCH in 1 BOX, UNIT-DOSE (50742-515-30) / 1 PATCH in 1 POUCHMarketed from Dec 6, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Nitro-Dur
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — 60 mg/1
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Ingenus Pharmaceuticals, LLCNDC labeler code 50742
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020145
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 50742-515_fcec90fc-83c9-15e2-e053-6394a90ab2d5SPL ID fcec90fc-83c9-15e2-e053-6394a90ab2d5SPL set ID 5e15296c-5acd-4bcc-80a8-b49cb1ef3eb0RxCUI 486146, 486148, 486152, 861657, 899521, 899607, 899642, 899660, 899688, 899690, 899703, 899705UNII 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
N450742051530followed by a unit qualifier and the quantityPackage 50742-0515-30. 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 . This label includes a boxed warning.
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.
About NDC 50742-515
- What is NDC 50742-515?
- 50742-515 is the product NDC for Nitro-Dur (nitroglycerin), Nitroglycerin 60 mg/1 patch, listed with the FDA by Ingenus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitro-Dur (Nitroglycerin).
- What is the active ingredient?
- Nitroglycerin.
- Who is the labeler?
- Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nitro-Dur?
- 5 other product NDCs are listed under this name. See all Nitro-Dur NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nitro-Dur products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nitro-Durnitroglycerin | Nitroglycerin 20 mg/1 | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-513 | 50742-0513-30 |
| Nitro-Durnitroglycerin | Nitroglycerin 40 mg/1 | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-514 | 50742-0514-30 |
| Nitro-Durnitroglycerin | Nitroglycerin 80 mg/1 | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-516 | 50742-0516-30 |
| Nitro-Durnitroglycerin | Nitroglycerin 120 mg/1 | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-517 | 50742-0517-30 |
| Nitro-Durnitroglycerin | Nitroglycerin 160 mg/1 | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-518 | 50742-0518-30 |
Other NDCs under NDA 020145
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nitro-Durnitroglycerin | Nitroglycerin 20 mg/1 | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-513 |
| Nitro-Durnitroglycerin | Nitroglycerin 40 mg/1 | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-514 |
| Nitro-Durnitroglycerin | Nitroglycerin 80 mg/1 | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-516 |
| Nitro-Durnitroglycerin | Nitroglycerin 120 mg/1 | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-517 |
| Nitro-Durnitroglycerin | Nitroglycerin 160 mg/1 | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-518 |
| Nitroglycerin Transdermal Infusion Systemnitroglycerin | Nitroglycerin 120 mg/1 | PatchTransdermal | Dr. Reddy's Laboratories, Inc. | 43598-893 |
| Nitroglycerin Transdermal Infusion Systemnitroglycerin | Nitroglycerin 80 mg/1 | PatchTransdermal | Dr. Reddy's Laboratories, Inc. | 43598-894 |
| Nitroglycerin Transdermal Infusion Systemnitroglycerin | Nitroglycerin 40 mg/1 | PatchTransdermal | Dr. Reddy's Laboratories, Inc. | 43598-895 |
| Nitroglycerin Transdermal Infusion Systemnitroglycerin | Nitroglycerin 20 mg/1 | PatchTransdermal | Dr. Reddy's Laboratories, Inc. | 43598-896 |