14550-519 : Glyburide 5 mg / Metformin Hydrochloride 500 mg Oral Tablet


NDC14550-519
Labeler: Actavis Pharma Manufacturing Pvt. Ltd.
Product Type: Human Prescription Drug
Drug Name:  Glyburide (Micronized) and Metformin Hydrochloride
Dosage Form: Oral Tablet
Application #: ANDA076716
Rev. Date: 


Appearance:


Markings: 753
Shapes:  Capsule
Colors:  Blue
Size (mm): 16
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.

NDC Package Codes:

  • 14550-519-02: 100 TABLET IN 1 BOTTLE (14550‑519‑02)
  • 14550-519-04: 500 TABLET IN 1 BOTTLE (14550‑519‑04)

Active Ingredients:

  • Glyburide
  • Metformin Hydrochloride

Dosage Strength:

  • 5 mg
  • 500 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Hypromellose
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polydextrose
  • Polyethylene Glycol
  • Povidone
  • Sodium Hydroxide
  • Sorbic Acid
  • Titanium Dioxide
  • Triacetin
  • Fd&c Blue No. 2
  • Fd&c Yellow No. 6
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)

Pharmaceutical Classes:

  • Sulfonylurea [EPC]
  • Sulfonylurea Compounds [Chemical/Ingredient]
  • Biguanide [EPC]
  • Biguanides [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 14550-517 Glyburide 1.25 mg / Metformin Hydrochloride 250 mg Oral Tablet by Actavis Pharma Manufacturing Pvt. Ltd.
  • 14550-518 Glyburide 2.5 mg / Metformin Hydrochloride 500 mg Oral Tablet by Actavis Pharma Manufacturing Pvt. Ltd.
  • 45963-751 Glyburide 1.25 mg / Metformin Hydrochloride 250 mg Oral Tablet by Actavis Inc.
  • 45963-752 Glyburide 2.5 mg / Metformin Hydrochloride 500 mg Oral Tablet by Actavis Inc.
  • 45963-753 Glyburide 5 mg / Metformin Hydrochloride 500 mg Oral Tablet by Actavis Inc.

NDC QR Code

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NDC 14550-519 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.