65162-957 : Esomeprazole 40 mg Delayed Release Capsule


NDC: 65162-957
Labeler: Amneal Pharmaceuticals of New York, LLC
Product Type: Human Prescription Drug
Drug Name:  Esomeprazole Strontium
Dosage Form: Oral Capsule, Delayed Release
Application #: NDA202342
Rev. Date: 


Appearance:


Markings: HMP40
Shapes:  Capsule
Colors:  Pink
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.

HMP40: (65162-957) Esomeprazole 40 mg Delayed Release Capsule by Amneal Pharmaceuticals of New York, LLC
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:

  • 65162-957-03: 30 CAPSULE, DELAYED RELEASE IN 1 BOTTLE (65162‑957‑03)

Active Ingredients:

  • Esomeprazole Strontium

Dosage Strength:

  • 40 mg

Inactive Ingredients:

  • Calcium Carbonate
  • Hypromelloses
  • Methacrylic Acid
  • Polysorbate 80
  • Sucrose
  • Talc
  • Triethyl Citrate
  • Gelatin
  • Titanium Dioxide
  • Fd&c Blue No. 1
  • Fd&c Red No. 40
  • Fd&c Yellow No. 6
  • Glyceryl Monostearate
  • Starch, Corn

Pharmaceutical Classes:

  • Proton Pump Inhibitor [EPC]
  • Proton Pump Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 65162-955 Esomeprazole 20 mg Delayed Release Capsule by Amneal Pharmaceuticals of New York, LLC
  • 52246-200 Esomeprazole Strontium 24.65 mg Oral Capsule, Delayed Release by Parapro LLC
  • 52246-400 Esomeprazole Strontium 49.3 mg Oral Capsule, Delayed Release by Parapro LLC
  • 53746-955 Esomeprazole 20 mg Delayed Release Capsule by Amneal Pharmaceuticals, LLC
  • 53746-957 Esomeprazole 40 mg Delayed Release Capsule by Amneal Pharmaceuticals, LLC
  • 69336-129 Esomeprazole Strontium 49.3 mg Oral Capsule, Delayed Release by Sterling-knight Pharmaceuticals, LLC
  • 70849-200 Esomeprazole Strontium 20 mg Oral Capsule, Delayed Release by R2 Pharma, LLC
  • 70849-400 Esomeprazole Strontium 40 mg Oral Capsule, Delayed Release by R2 Pharma, LLC

NDC QR Code

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NDC 65162-957 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.