Prescription drug · ANDA
Bisoprolol Fumarate and Hydrochlorothiazide NDC 0378-0505
Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0505-01 | 0037805050100378050501 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0505-01)Marketed from Feb 22, 2021 |
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)
- Bisoprolol Fumarate and Hydrochlorothiazide
- Generic name (nonproprietary)
- bisoprolol fumarate and hydrochlorothiazide
- Active ingredients
- Bisoprolol fumarate — 10 mg/1Hydrochlorothiazide — 6.25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075768
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 0378-0505_05ad15d0-4472-45a9-8dd6-fc5d13c2a858SPL ID 05ad15d0-4472-45a9-8dd6-fc5d13c2a858SPL set ID d4243a76-516c-417e-80ba-444a21ecc688RxCUI 854908, 854916, 854919UNII 0J48LPH2TH, UR59KN573L
- 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
N400378050501followed by a unit qualifier and the quantityPackage 00378-0505-01. 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 0378-0505
- What is NDC 0378-0505?
- 0378-0505 is the product NDC for Bisoprolol Fumarate and Hydrochlorothiazide, Bisoprolol fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-113 | 72578-0113-0172578-0113-0572578-0113-06 |
| 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 |
Other NDCs under ANDA 075768
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 | Mylan Pharmaceuticals Inc. | 0378-0501 |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-0503 |