Prescription drug · ANDA
Nitro-Bid (nitroglycerin) NDC 0281-0326
Nitroglycerin 20 mg/g · Ointment · Topical · Savage Laboratories a division of Fougera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0281-0326-08 | 00281032608 | 48 PACKET in 1 BOX (0281-0326-08) / 1 g in 1 PACKETMarketed from Aug 17, 2009 | |
| 0281-0326-30 | 00281032630 | 30 g in 1 TUBE (0281-0326-30)Marketed from Aug 17, 2009 | |
| 0281-0326-60 | 00281032660 | 60 g in 1 TUBE (0281-0326-60)Marketed from Aug 17, 2009 |
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)
- Nitro-Bid
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — 20 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087355
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 0281-0326_0011b0f7-715e-4daf-9e6b-a787a83e18f6SPL ID 0011b0f7-715e-4daf-9e6b-a787a83e18f6SPL set ID e464e9bb-48e8-4b9f-9fff-e220cfbac0c5RxCUI 207273, 242946UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400281032608followed by a unit qualifier and the quantityPackage 00281-0326-08. 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 ointment is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 087355
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 20 mg/g | OintmentTopical | HF Acquisition Co LLC, DBA HealthFirst | 51662-1340 |