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Amnesteem

NDC 0378-6613, isotretinoin, capsule, from Mylan Pharmaceuticals Inc..

Product NDC
0378-6613
Status
Listed
Labeler
Mylan Pharmaceuticals Inc.
Dosage form
CAPSULE
Route
ORAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
ANDA
Application
ANDA075945
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/0378-6613 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • ISOTRETINOIN30 mg/1

Pharmacologic classes

Retinoid [EPC]; Retinoids [CS]

Package NDCNDC-11Package
0378-6613-93003786613933 BLISTER PACK in 1 CARTON (0378-6613-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6613-85)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/b2cb63c9-f825-4991-9a2c-6260f1bbcc2c

  • NADAC price for package 00378661393

    GET /v1/drugs/nadac/00378661393

Use it

Look up 0378-6613 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/0378-6613 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 0378-6613. 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.