Prescription drug · ANDA
isosorbide dinitrate and hydralazine hydrochloride NDC 72319-012
Isosorbide dinitrate 20 mg/1; Hydralazine hydrochloride 37.5 mg/1 · Tablet, Film coated · Oral · i3 Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72319-012-03 | 72319001203 | 90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03)Marketed from Feb 7, 2024 | |
| 72319-012-18 | 72319001218 | 180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18)Marketed from Feb 7, 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)
- isosorbide dinitrate and hydralazine hydrochloride
- Generic name (nonproprietary)
- isosorbide dinitrate and hydralazine hydrochloride
- Active ingredients
- Isosorbide dinitrate — 20 mg/1Hydralazine hydrochloride — 37.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- i3 Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215988
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 72319-012_1898d58a-a951-f2a3-e063-6394a90a5e9fSPL ID 1898d58a-a951-f2a3-e063-6394a90a5e9fSPL set ID cacf1a7c-0388-09ee-e053-2995a90a10cfRxCUI 905377UNII IA7306519N, FD171B778YUPC 0372319012037
- Pharmacologic class
- Arteriolar Vasodilator; 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
N472319001203followed by a unit qualifier and the quantityPackage 72319-0012-03. 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)
Isosorbide dinitrate and hydralazine hydrochloride tablets are a combination of isosorbide dinitrate, a nitrate vasodilator, and hydralazine hydrochloride, an arteriolar vasodilator, indicated for: the treatment of heart failure as an adjunct therapy to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status ( 1.1 ) Limitations of use: There is little experience in patients with NYHA class IV heart failure ( 1.2 ) 1.1 Treatment of Heart Failure in Self-identified Black Patients Isosorbide dinitrate and hydralazine hydrochloride tablets are indicated for the treatment of heart f…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215988
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 dinitrate and hydralazine hydrochloride | Isosorbide dinitrate 20 mg/1; Hydralazine hydrochloride 37.5 mg/1 | Tablet, Film coatedOral | A2A Integrated Pharmaceuticals | 73141-012 |