Prescription drug · ANDA
Nitroglycerin NDC 43598-436
Nitroglycerin .4 mg/1 · Tablet · Sublingual · Dr. Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-436-01 | 43598043601 | 100 TABLET in 1 BOTTLE (43598-436-01)Marketed from Aug 29, 2016 | |
| 43598-436-11 | 43598043611 | 4 BOTTLE in 1 CARTON (43598-436-11) / 25 TABLET in 1 BOTTLE (43598-436-35)Marketed from Aug 29, 2016 |
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
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — .4 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Dr. Reddys Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208191
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 43598-436_b6f146c9-be21-75da-dc27-e968a5f760aeSPL ID b6f146c9-be21-75da-dc27-e968a5f760aeSPL set ID c555f8de-477f-0225-98a2-baf8945bbd63RxCUI 198038, 198039, 198040UNII G59M7S0WS3UPC 0343598437019, 0343598436357, 0343598436012
- 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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443598043601followed by a unit qualifier and the quantityPackage 43598-0436-01. 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 .
Indications (excerpt from the label)
Nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin is a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208191
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 | Nitroglycerin .3 mg/1 | TabletSublingual | Dr. Reddys Laboratories Inc | 43598-435 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | HF Acquisition Co LLC, DBA HealthFirst | 51662-1282 |
| Nitroglycerin | Nitroglycerin .3 mg/1 | TabletSublingual | Golden State Medical Supply, Inc. | 60429-839 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Golden State Medical Supply, Inc. | 60429-840 |
| Nitroglycerin | Nitroglycerin .6 mg/1 | TabletSublingual | Golden State Medical Supply, Inc. | 60429-841 |
| Nitroglycerin | Nitroglycerin .6 mg/1 | TabletSublingual | Dr. Reddys Laboratories Inc | 43598-437 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | A-S Medication Solutions | 50090-3266 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Medical Purchasing Solutions, LLC | 71872-7010 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Proficient Rx LP | 71205-225 |