Prescription drug · NDA
Nitrostat (Nitroglycerin tablet) NDC 0404-9800
Nitroglycerin .4 mg/1 · Tablet · Sublingual · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9800-01 | 0040498000100404980001 | 1 BOTTLE in 1 BAG (0404-9800-01) / 25 TABLET in 1 BOTTLEMarketed from Sep 17, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Nitrostat
- Generic name (nonproprietary)
- nitroglycerin tablet
- Active ingredients
- Nitroglycerin — .4 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Henry Schein, Inc.NDC labeler code 0404
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021134
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 0404-9800_32b2fbb8-8769-4399-9cb6-7183cb7072ffSPL ID 32b2fbb8-8769-4399-9cb6-7183cb7072ffSPL set ID 5265648f-3062-48a2-a4e3-fea1207807a8RxCUI 198039, 207346UNII 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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400404980001followed by a unit qualifier and the quantityPackage 00404-9800-01. 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)
NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. INDICATIONS AND USAGE NITROSTAT 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.
About NDC 0404-9800
- What is NDC 0404-9800?
- 0404-9800 is the product NDC for Nitrostat (nitroglycerin tablet), Nitroglycerin .4 mg/1 tablet, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrostat (Nitroglycerin tablet).
- What is the active ingredient?
- Nitroglycerin.
- Who is the labeler?
- Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nitrostat?
- 5 other product NDCs are listed under this name. See all Nitrostat NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nitrostat products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nitrostatnitroglycerin | Nitroglycerin .3 mg/1 | TabletSublingual | Viatris Specialty LLC | 58151-309 | 58151-0309-01 |
| Nitrostatnitroglycerin | Nitroglycerin .6 mg/1 | TabletSublingual | Viatris Specialty LLC | 58151-311 | 58151-0311-01 |
| Nitrostatnitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | A-S Medication Solutions | 50090-7203 | 50090-7203-00 |
| Nitrostatnitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Viatris Specialty LLC | 58151-310 | 58151-0310-0158151-0310-52 |
| Nitrostatnitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Proficient Rx LP | 63187-884 | 63187-0884-25 |
Other NDCs under NDA 021134
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 .6 mg/1 | TabletSublingual | Mylan Pharmaceuticals Inc. | 59762-0489 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Mylan Pharmaceuticals Inc. | 59762-3304 |
| Nitroglycerin | Nitroglycerin .3 mg/1 | TabletSublingual | Mylan Pharmaceuticals Inc. | 59762-4921 |
| Nitrostatnitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | A-S Medication Solutions | 50090-7203 |
| Nitrostatnitroglycerin | Nitroglycerin .3 mg/1 | TabletSublingual | Viatris Specialty LLC | 58151-309 |
| Nitrostatnitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Viatris Specialty LLC | 58151-310 |
| Nitrostatnitroglycerin | Nitroglycerin .6 mg/1 | TabletSublingual | Viatris Specialty LLC | 58151-311 |
| Nitrostatnitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Proficient Rx LP | 63187-884 |