Prescription drug · NDA
Nitrolingual (Nitroglycerin) NDC 21724-100
Nitroglycerin 400 ug/1 · Spray · Oral · INDEPENDENCE PHARMACEUTICALS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21724-100-41 | 2172401004121724010041 | 1 BOTTLE, SPRAY in 1 CARTON (21724-100-41) / 200 SPRAY in 1 BOTTLE, SPRAYMarketed from Dec 2, 2024 | |
| 21724-100-50 | 2172401005021724010050 | 1 BOTTLE, SPRAY in 1 CARTON (21724-100-50) / 60 SPRAY in 1 BOTTLE, SPRAYMarketed from Dec 2, 2024 |
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)
- Nitrolingual
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — 400 ug/1
- Dosage form
- Spray
- Route
- Oral
- Labeler
- INDEPENDENCE PHARMACEUTICALS, LLCNDC labeler code 21724
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018705
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 21724-100_71e0fc6a-41c8-4463-95c3-17335702a210SPL ID 71e0fc6a-41c8-4463-95c3-17335702a210SPL set ID d19b5f51-ca85-48d6-9ccd-8ae26249cdc3RxCUI 705129, 995019UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N421724010041followed by a unit qualifier and the quantityPackage 21724-0100-41. 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)
Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Nitrolingual Pumpspray is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 21724-100
- What is NDC 21724-100?
- 21724-100 is the product NDC for Nitrolingual (nitroglycerin), Nitroglycerin 400 ug/1 spray, listed with the FDA by INDEPENDENCE PHARMACEUTICALS, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrolingual (Nitroglycerin).
- What is the active ingredient?
- Nitroglycerin.
- Who is the labeler?
- INDEPENDENCE PHARMACEUTICALS, LLC, NDC labeler code 21724. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nitrolingual?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 018705
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 400 ug/1 | SprayOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1672 |
| Nitroglycerin | Nitroglycerin 400 ug/1 | SprayOral | Prasco Laboratories | 66993-241 |
| Nitroglycerin | Nitroglycerin 400 ug/1 | SprayOral | Sportpharm LLC | 85766-294 |
| Nitroglycerin Lingualnitroglycerin | Nitroglycerin 400 ug/1 | SprayOral | Allegis Pharmaceuticals, LLC | 28595-120 |
| Nitroglycerin Lingual | Nitroglycerin 400 ug/1 | SprayOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1519 |