Prescription drug · ANDA
nitroglycerin lingual (Nitroglycerin) NDC 45802-210
Nitroglycerin 400 ug/1 · Spray · Oral · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-210-01 | 4580202100145802021001 | 1 BOTTLE in 1 CARTON (45802-210-01) / 60 SPRAY in 1 BOTTLEMarketed from Sep 20, 2013 | |
| 45802-210-02 | 4580202100245802021002 | 1 BOTTLE in 1 CARTON (45802-210-02) / 200 SPRAY in 1 BOTTLEMarketed from Sep 20, 2013 |
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 lingual
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — 400 ug/1
- Dosage form
- Spray
- Route
- Oral
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091496
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 45802-210_e75425f2-a532-4b73-9b24-258a7dcc34b9SPL ID e75425f2-a532-4b73-9b24-258a7dcc34b9SPL set ID e7bbeff1-e4f1-43a6-a1b3-a8c3dcae817dRxCUI 705129UNII 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
N445802021001followed by a unit qualifier and the quantityPackage 45802-0210-01. 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 Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin Lingual Spray 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 45802-210
- What is NDC 45802-210?
- 45802-210 is the product NDC for nitroglycerin lingual (nitroglycerin), Nitroglycerin 400 ug/1 spray, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- nitroglycerin lingual (Nitroglycerin).
- What is the active ingredient?
- Nitroglycerin.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for nitroglycerin lingual?
- 4 other product NDCs are listed under this name. See all nitroglycerin lingual NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other nitroglycerin lingual products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nitroglycerin Lingual | Nitroglycerin 400 ug/1 | SprayOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1519 | 51662-1519-0151662-1519-02 |
| Nitroglycerin Lingual | Nitroglycerin 400 ug/1 | SprayOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1393 | 51662-1393-01 |
| Nitroglycerin Lingual | Nitroglycerin 400 ug/1 | SprayOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1423 | 51662-1423-01 |
| Nitroglycerin Lingualnitroglycerin | Nitroglycerin 400 ug/1 | SprayOral | Allegis Pharmaceuticals, LLC | 28595-120 | 28595-0120-49 |
Other NDCs under ANDA 091496
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 Lingual | Nitroglycerin 400 ug/1 | SprayOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1393 |
| Nitroglycerin Lingual | Nitroglycerin 400 ug/1 | SprayOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1423 |