Prescription drug · ANDA
Bisoprolol Fumarate and Hydrochlorothiazide NDC 72578-113
Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 · Tablet, Film coated · Oral · Viona Pharmaceuticals Inc
NDC codes
FDA NDC DirectoryProduct NDC (as listed)72578-113Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72578-0113Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-113-01 | 7257801130172578011301 | 100 TABLET, FILM COATED in 1 BOTTLE (72578-113-01)Marketed from Mar 1, 2023 | |
| 72578-113-05 | 7257801130572578011305 | 500 TABLET, FILM COATED in 1 BOTTLE (72578-113-05)Marketed from Mar 1, 2023 | |
| 72578-113-06 | 7257801130672578011306 | 30 TABLET, FILM COATED in 1 BOTTLE (72578-113-06)Marketed from Mar 1, 2023 |
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)
- Bisoprolol Fumarate and Hydrochlorothiazide
- Generic name (nonproprietary)
- bisoprolol fumarate and hydrochlorothiazide
- Active ingredients
- Bisoprolol fumarate — 2.5 mg/1Hydrochlorothiazide — 6.25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Viona Pharmaceuticals IncNDC labeler code 72578
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215666
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 72578-113_3466b097-8648-4110-a130-8754da1f2739SPL ID 3466b097-8648-4110-a130-8754da1f2739SPL set ID 57505d73-f2a8-430b-8703-a0a6bb733c7dRxCUI 854908, 854916, 854919UNII 0J48LPH2TH, UR59KN573LUPC 0372578114060, 0372578115067
- Pharmacologic class
- Thiazide Diuretic; beta-Adrenergic Blocker
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
N472578011301followed by a unit qualifier and the quantityPackage 72578-0113-01. 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)
INDICATIONS AND USAGE Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.
Excerpt only. Read the full label for complete information.
About NDC 72578-113
- What is NDC 72578-113?
- 72578-113 is the product NDC for Bisoprolol Fumarate and Hydrochlorothiazide, Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 tablet, film coated, listed with the FDA by Viona Pharmaceuticals Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bisoprolol Fumarate and Hydrochlorothiazide.
- What is the active ingredient?
- Bisoprolol fumarate, Hydrochlorothiazide.
- Who is the labeler?
- Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bisoprolol Fumarate and Hydrochlorothiazide?
- 38 other product NDCs are listed under this name. See all Bisoprolol Fumarate and Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bisoprolol Fumarate and Hydrochlorothiazide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-678 | 59651-0678-0159651-0678-0559651-0678-30 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-679 | 59651-0679-0159651-0679-0559651-0679-30 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-680 | 59651-0680-0159651-0680-0559651-0680-30 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1760 | 70771-1760-0170771-1760-0370771-1760-05 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1761 | 70771-1761-0170771-1761-0370771-1761-05 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1762 | 70771-1762-0170771-1762-0370771-1762-05 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-114 | 72578-0114-0172578-0114-0572578-0114-06 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-115 | 72578-0115-0172578-0115-0572578-0115-06 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-740 | 10135-0740-0110135-0740-05 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-741 | 10135-0741-0110135-0741-05 |
Other NDCs under ANDA 215666
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 |
|---|---|---|---|---|
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1760 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1761 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1762 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-114 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-115 |