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Diclofenac Sodium and Misoprostol

NDC 0591-0397, Diclofenac Sodium and Misoprostol, tablet, delayed release, from Actavis Pharma, Inc..

Product NDC
0591-0397
Status
Listed
Labeler
Actavis Pharma, Inc.
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
ANDA
Application
ANDA201089
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/0591-0397 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • DICLOFENAC SODIUM50 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
0591-0397-190059103971990 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-19)
0591-0397-600059103976060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/df8b8660-0c24-4848-8bea-c1b935090c66

  • NADAC price for package 00591039719

    GET /v1/drugs/nadac/00591039719

  • NADAC price for package 00591039760

    GET /v1/drugs/nadac/00591039760

Use it

Look up 0591-0397 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/0591-0397 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 0591-0397. 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.