0006-0078 : Janumet XR 50/500 24 Hr Extended Release Tablet


NDC0006-0078
Labeler: Merck Sharp & Dohme Corp.
Product Type: Human Prescription Drug
Drug Name:  Janumet XR
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA202270
Rev. Date: 


Appearance:


Markings: 78
Shapes:  Oval
Colors:  Blue
Size (mm): 21
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.

78: (0006-0078) Janumet XR 50/500 24 Hr Extended Release Tablet by Merck Sharp & Dohme Corp.
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:

  • 0006-0078-28: 2 BOTTLE IN 1 CARTON (0006‑0078‑28) > 14 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0006‑0078‑14)
  • 0006-0078-61: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0006‑0078‑61)
  • 0006-0078-62: 180 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0006‑0078‑62)
  • 0006-0078-82: 1000 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0006‑0078‑82)

Active Ingredients:

  • Metformin Hydrochloride
  • Sitagliptin Phosphate

Dosage Strength:

  • 500 mg
  • 50 mg

Inactive Ingredients:

  • Povidone K29/32
  • Hypromellose 2208 (100000 Mpa.s)
  • Silicon Dioxide
  • Sodium Stearyl Fumarate
  • Propyl Gallate
  • Polyethylene Glycol 3350
  • Kaolin
  • Hypromellose 2910 (6 Mpa.s)
  • Hydroxypropyl Cellulose (Type H)
  • Titanium Dioxide
  • Fd&c Blue No. 2
  • Indigotindisulfonate Sodium
  • Aluminum Oxide
  • Carnauba Wax
  • Cellulose, Microcrystalline

Pharmaceutical Classes:

  • Dipeptidyl Peptidase 4 Inhibitor [EPC]
  • Dipeptidyl Peptidase 4 Inhibitors [MoA]
  • Biguanide [EPC]
  • Biguanides [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 0006-0080 Janumet XR 50/1000 24 Hr Extended Release Tablet by Merck Sharp & Dohme Corp.
  • 0006-0081 Janumet XR 100/1000 24 Hr Extended Release Tablet by Merck Sharp & Dohme Corp.
  • 0006-0575 Janumet 50 mg/500 mg Oral Tablet by Merck Sharp & Dohme Corp.
  • 0006-0577 Janumet 50 mg/1000 mg Oral Tablet by Merck Sharp & Dohme Corp.
  • 35356-136 Janumet 50 mg/500 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 52125-486 Janumet 50 mg/500 mg Oral Tablet by Remedyrepack Inc.
  • 52125-493 Janumet 50 mg/1000 mg Oral Tablet by Remedyrepack Inc.
  • 54868-1097 Janumet 50 mg/1000 mg Oral Tablet by Physicians Total Care, Inc.
  • 54868-5973 Janumet 50 mg/500 mg Oral Tablet by Physicians Total Care, Inc.
  • 70518-2548 Janumet Oral Tablet, Film Coated by Remedyrepack Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 0006-0078 QR Code

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