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VARENICLINE

NDC 53401-032, VARENICLINE, tablet, film coated, from Aphena Pharma Solutions - Tennessee, LLC.

Product NDC
53401-032
Status
Listed
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Dosage form
TABLET, FILM COATED
Route
ORAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
ANDA
Application
ANDA201962
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/53401-032 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • VARENICLINE TARTRATE1 mg/1

Pharmacologic classes

Cholinergic Agonists [MoA]; Cholinergic Receptor Agonist [EPC]; Partial Cholinergic Nicotinic Agonist [EPC]; Partial Cholinergic Nicotinic Agonists [MoA]

Package NDCNDC-11Package
53401-032-84534010032841008 TABLET, FILM COATED in 1 BOTTLE (53401-032-84)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/59e125e3-5204-122b-e063-6394a90a0092

Use it

Look up 53401-032 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/53401-032 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 53401-032. 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.