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NDC 10631-116, isotretinoin, capsule, from Sun Pharmaceutical Industries, Inc..

Product NDC
10631-116
Status
Listed
Labeler
Sun Pharmaceutical Industries, Inc.
Dosage form
CAPSULE
Route
ORAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
NDA
Application
NDA021951
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/10631-116 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • ISOTRETINOIN20 mg/1

Pharmacologic classes

Retinoid [EPC]; Retinoids [CS]

Package NDCNDC-11Package
10631-116-31106310116313 BLISTER PACK in 1 BOX (10631-116-31) / 10 CAPSULE in 1 BLISTER PACK (10631-116-69)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/3ef0cff8-19c1-4441-b780-fca6c7ee1615

  • NADAC price for package 10631011631

    GET /v1/drugs/nadac/10631011631

Use it

Look up 10631-116 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/10631-116 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 10631-116. 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.