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
  • 50090-5502 Janumet Oral Tablet, Film Coated by A-s Medication Solutions
  • 50090-5503 Janumet Oral Tablet, Film Coated by A-s Medication Solutions
  • 50090-5616 Janumet Oral Tablet, Film Coated by A-s Medication Solutions
  • 50090-5618 Janumet Oral Tablet, Film Coated by A-s Medication Solutions
  • 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

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NDC 0006-0078 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.