Prescription drug · NDA AUTHORIZED GENERIC
isosorbide dinitrate and hydralazine hydrochloride NDC 52536-006
hydralazine hydrochloride and isosorbide dinitrate · Hydralazine hydrochloride 37.5 mg/1; Isosorbide dinitrate 20 mg/1 · Tablet, Film coated · Oral · Wilshire Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52536-006-09 | 5253600060952536000609 | 90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09)Marketed from Apr 15, 2022 |
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)
- hydralazine hydrochloride and isosorbide dinitrate
- Active ingredients
- Hydralazine hydrochloride — 37.5 mg/1Isosorbide dinitrate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Wilshire PharmaceuticalsNDC labeler code 52536
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020727
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 52536-006_13386839-9eb4-4956-a788-d94a7b63cb77SPL ID 13386839-9eb4-4956-a788-d94a7b63cb77SPL set ID 620a0680-aad0-4923-84be-7393c0cbdcbdRxCUI 905377UNII FD171B778Y, IA7306519NUPC 0352536006095
- 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
N452536000609followed by a unit qualifier and the quantityPackage 52536-0006-09. 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.
About NDC 52536-006
- What is NDC 52536-006?
- 52536-006 is the product NDC for isosorbide dinitrate and hydralazine hydrochloride, Hydralazine hydrochloride 37.5 mg/1; Isosorbide dinitrate 20 mg/1 tablet, film coated, listed with the FDA by Wilshire Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- isosorbide dinitrate and hydralazine hydrochloride (Hydralazine hydrochloride and isosorbide dinitrate).
- What is the active ingredient?
- Hydralazine hydrochloride, Isosorbide dinitrate.
- Who is the labeler?
- Wilshire Pharmaceuticals, NDC labeler code 52536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for isosorbide dinitrate and hydralazine hydrochloride?
- 4 other product NDCs are listed under this name. See all isosorbide dinitrate and hydralazine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other isosorbide dinitrate and hydralazine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| isosorbide dinitrate and hydralazine hydrochloride | Isosorbide dinitrate 20 mg/1; Hydralazine hydrochloride 37.5 mg/1 | Tablet, Film coatedOral | A2A Integrated Pharmaceuticals | 73141-012 | 73141-0012-0373141-0012-18 |
| isosorbide dinitrate and hydralazine hydrochloride | Isosorbide dinitrate 20 mg/1; Hydralazine hydrochloride 37.5 mg/1 | Tablet, Film coatedOral | i3 Pharmaceuticals, LLC | 72319-012 | 72319-0012-0372319-0012-18 |
| isosorbide dinitrate and hydralazine hydrochloridehydralazine hydrochloride and isosorbide dinitrate | Hydralazine hydrochloride 37.5 mg/1; Isosorbide dinitrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2343 | 72162-2343-09 |
| Isosorbide dinitrate and hydralazine hydrochloride | Hydralazine hydrochloride 37.5 mg/1; Isosorbide dinitrate 20 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-246 | 50742-0246-1850742-0246-90 |
Other NDCs under NDA 020727
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 |
|---|---|---|---|---|
| BiDilhydralazine hydrochloride and isosorbide dinitrate | Hydralazine hydrochloride 37.5 mg/1; Isosorbide dinitrate 20 mg/1 | Tablet, Film coatedOral | Azurity Pharmaceuticals, Inc. | 24338-010 |
| isosorbide dinitrate and hydralazine hydrochloridehydralazine hydrochloride and isosorbide dinitrate | Hydralazine hydrochloride 37.5 mg/1; Isosorbide dinitrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2343 |