0378-0503 : Bisoprolol Fumarate 5 mg / Hctz 6.25 mg Oral Tablet


NDC: 0378-0503
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name: Bisoprolol Fumarate and Hydrochlorothiazide
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA075768
Rev. Date: 


Appearance:


Markings: M;503
Shapes:  Round
Colors:  Blue
Size (mm): 7
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

M 503: (0378-0503) Bisoprolol Fumarate 5 mg / Hctz 6.25 mg Oral Tablet by Mylan Pharmaceuticals Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 0378-0503-01: 100 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑0503‑01)
  • 0378-0503-05: 500 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑0503‑05)
  • 0378-0503-10: 1000 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑0503‑10)

Active Ingredients:

  • Bisoprolol Fumarate
  • Hydrochlorothiazide

Dosage Strength:

  • 5 mg
  • 6.25 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Hypromelloses
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polydextrose
  • Polyethylene Glycols
  • Starch, Corn
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Fd&c Blue No. 2
  • Fd&c Yellow No. 6

Pharmaceutical Classes:

  • Adrenergic beta-Antagonists [MoA]
  • beta-Adrenergic Blocker [EPC]
  • Increased Diuresis [PE]
  • Thiazide Diuretic [EPC]
  • Thiazides [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 0378-0501 Bisoprolol Fumarate 2.5 mg / Hctz 6.25 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-0505 Bisoprolol Fumarate 10 mg / Hctz 6.25 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0093-3241 Bisoprolol Fumarate and Hydrochlorothiazide Oral Tablet, Film Coated by Teva Pharmaceuticals USA, Inc.
  • 0093-3242 Bisoprolol Fumarate and Hydrochlorothiazide Oral Tablet, Film Coated by Teva Pharmaceuticals USA, Inc.
  • 0093-3243 Bisoprolol Fumarate and Hydrochlorothiazide Oral Tablet, Film Coated by Teva Pharmaceuticals USA, Inc.
  • 0185-0701 Bisoprolol Fumarate 2.5 mg / Hctz 6.25 mg Oral Tablet by Eon Labs, Inc.
  • 0185-0704 Bisoprolol Fumarate 5 mg / Hctz 6.25 mg Oral Tablet by Eon Labs, Inc.
  • 0185-0707 Bisoprolol Fumarate 10 mg / Hctz 6.25 mg Oral Tablet by Eon Labs, Inc.
  • 10135-740 Bisoprolol Fumarate and Hydrochlorothiazide Oral Tablet by Marlex Pharmaceuticals, Inc.
  • 10135-741 Bisoprolol Fumarate and Hydrochlorothiazide Oral Tablet by Marlex Pharmaceuticals, Inc.
  • 10135-742 Bisoprolol Fumarate and Hydrochlorothiazide Oral Tablet by Marlex Pharmaceuticals, Inc.
  • 10544-173 Bisoprolol Fumarate and Hydrochlorothiazide Oral Tablet by Blenheim Pharmacal, Inc.
  • 10544-174 Bisoprolol Fumarate and Hydrochlorothiazide Oral Tablet by Blenheim Pharmacal, Inc.
  • 10544-563 Bisoprolol Fumarate and Hydrochlorothiazide Oral Tablet by Blenheim Pharmacal, Inc.
  • 21695-808 Bisoprolol Fumarate 5 mg / Hctz 6.25 mg Oral Tablet by Rebel Distributors Corp
  • 21695-809 Bisoprolol Fumarate 10 mg / Hctz 6.25 mg Oral Tablet by Rebel Distributors Corp
  • 29300-187 Bisoprolol Fumarate 2.5 mg / Hctz 6.25 mg Oral Tablet by Unichem Pharmaceuticals (Usa), Inc.
  • 29300-188 Bisoprolol Fumarate 5 mg / Hctz 6.25 mg Oral Tablet by Unichem Pharmaceuticals (Usa), Inc.
  • 29300-189 Bisoprolol Fumarate 10 mg / Hctz 6.25 mg Oral Tablet by Unichem Pharmaceuticals (Usa), Inc.
  • 33261-918 Bisoprolol Fumarate and Hydrochlorothiazide Oral Tablet by Aidarex Pharmaceuticals LLC
  • More related products ...

NDC QR Code

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NDC 0378-0503 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.