Prescription drug · ANDA
Isosorbide Mononitrate NDC 71335-2194
Isosorbide mononitrate 30 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2194-1 | 71335219401 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-1)Marketed from Apr 3, 2024 | |
| 71335-2194-2 | 71335219402 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-2)Marketed from Sep 6, 2023 | |
| 71335-2194-3 | 71335219403 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-3)Marketed from Apr 11, 2023 | |
| 71335-2194-4 | 71335219404 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-4)Marketed from Nov 18, 2022 | |
| 71335-2194-5 | 71335219405 | 10 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-5)Marketed from Apr 3, 2024 | |
| 71335-2194-6 | 71335219406 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-6)Marketed from Apr 3, 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)
- Isosorbide Mononitrate
- Generic name (nonproprietary)
- isosorbide mononitrate
- Active ingredients
- Isosorbide mononitrate — 30 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210918
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 71335-2194_a862daa7-dcfb-4f6e-90db-b712a7829fe8SPL ID a862daa7-dcfb-4f6e-90db-b712a7829fe8SPL set ID 441ddd35-6cb8-44d0-8009-1635390ede83RxCUI 317110UNII LX1OH63030
- 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
N471335219401followed by a unit qualifier and the quantityPackage 71335-2194-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 210918
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 |
|---|---|---|---|---|
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-922 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-175 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-176 |
| Isosorbide Mononitrate | Isosorbide mononitrate 120 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-177 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-772 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7038 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-788 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-208 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-825 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-209 |
| Isosorbide Mononitrate | Isosorbide mononitrate 120 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-210 |
| Isosorbide Mononitrate | Isosorbide mononitrate 60 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2192 |
| Isosorbide Mononitrate | Isosorbide mononitrate 30 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5686 |