Prescription drug · ANDA
Nitroglycerin NDC 70518-4232
Nitroglycerin 5 mg/mL · Injection, Solution · Intravenous · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4232-0 | 70518423200 | 25 VIAL, SINGLE-DOSE in 1 TRAY (70518-4232-0) / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4232-1)Marketed from Nov 14, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072034
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 70518-4232_5a6cf23f-bf2e-6a57-e063-6394a90a0976SPL ID 5a6cf23f-bf2e-6a57-e063-6394a90a0976SPL set ID b8af0974-33ea-4dd5-9ff7-3b61272aeb25RxCUI 237205UNII 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 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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470518423200followed by a unit qualifier and the quantityPackage 70518-4232-00. 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)
INDICATIONS AND USAGE Nitroglycerin Injection is indicated for treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and β -blockers; and for induction of intraoperative hypotension.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 072034
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 5 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-4810 |
| Nitroglycerin | Nitroglycerin 5 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9928 |
| Nitroglycerin | Nitroglycerin 5 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1386 |