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Naltrexone Hydrochloride

NDC 53401-008, Naltrexone Hydrochloride, tablet, film coated, from Aphena Pharma Solutions - Tennessee, LLC.

Product NDC
53401-008
Status
Listed
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Dosage form
TABLET, FILM COATED
Route
ORAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
ANDA
Application
ANDA075274
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/53401-008 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • NALTREXONE HYDROCHLORIDE50 mg/1

Pharmacologic classes

Opioid Antagonist [EPC]; Opioid Antagonists [MoA]

Package NDCNDC-11Package
53401-008-3153401000831600 TABLET, FILM COATED in 1 BOTTLE (53401-008-31)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/4f720879-1772-e734-e063-6394a90a0cf4

Use it

Look up 53401-008 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/53401-008 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 53401-008. Tell me the product, its labeler, dosage form and route, its packages, and the RxNorm concepts it maps to.

Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.