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Diclofenac Sodium and Misoprostol

NDC 65162-438, Diclofenac Sodium and Misoprostol, tablet, delayed release, from Amneal Pharmaceuticals LLC.

Product NDC
65162-438
Status
Listed
Labeler
Amneal Pharmaceuticals LLC
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
ANDA
Application
ANDA203995
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/65162-438 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • DICLOFENAC SODIUM75 mg/1
  • MISOPROSTOL200 ug/1

Pharmacologic classes

Anti-Inflammatory Agents, Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Decreased Prostaglandin Production [PE]; Nonsteroidal Anti-inflammatory Drug [EPC]; Prostaglandin E1 Analog [EPC]; Prostaglandins E, Synthetic [CS]

Package NDCNDC-11Package
65162-438-036516204380330 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-03)
65162-438-066516204380660 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-06)
65162-438-1065162043810100 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-10)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/afd30051-8f59-474b-9972-962a5a871dfb

  • NADAC price for package 65162043806

    GET /v1/drugs/nadac/65162043806

Use it

Look up 65162-438 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/65162-438 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 65162-438. Tell me the product, its labeler, dosage form and route, its packages, and the RxNorm concepts it maps to.
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Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.