Prescription drug · NDA AUTHORIZED GENERIC
Nitroglycerin Transdermal Infusion System NDC 43598-894
nitroglycerin · Nitroglycerin 80 mg/1 · Patch · Transdermal · Dr. Reddy's Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-894-30 | 43598089430 | 30 POUCH in 1 BOX, UNIT-DOSE (43598-894-30) / 1 PATCH in 1 POUCHMarketed from Mar 1, 2020 |
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)
- Nitroglycerin Transdermal Infusion System
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — 80 mg/1
- Dosage form
- Patch
- Route
- Transdermal
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020145
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 43598-894_10b34299-d60a-f785-70d6-2e5cc344638cSPL ID 10b34299-d60a-f785-70d6-2e5cc344638cSPL set ID 4f85d2e0-2e37-fcd1-276d-5a6466554289RxCUI 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
N443598089430followed by a unit qualifier and the quantityPackage 43598-0894-30. 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.
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 |
|---|---|---|---|---|
| Nitroglycerin Transdermal Infusion Systemnitroglycerin | Nitroglycerin 120 mg/1 | PatchTransdermal | Dr. Reddy's Laboratories, Inc. | 43598-893 |
| 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 |
| Nitro-Durnitroglycerin | Nitroglycerin 60 mg/1 | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-515 |
| 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 |