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Nicotine Polacrilex Gum

NDC 63443-5057, Nicotine Polacrilex, gum, chewing, from Fertin Pharma A/S.

Product NDC
63443-5057
Status
Listed
Labeler
Fertin Pharma A/S
Dosage form
GUM, CHEWING
Route
BUCCAL
Product type
HUMAN OTC DRUG
Marketing category
ANDA
Application
ANDA214354
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/63443-5057 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • NICOTINE4 mg/1

Pharmacologic classes

Cholinergic Nicotinic Agonist [EPC]; Nicotine [CS]

Package NDCNDC-11Package
63443-5057-16344350570110 BLISTER PACK in 1 CARTON (63443-5057-1) / 10 GUM, CHEWING in 1 BLISTER PACK

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

No FDA label, Medicare Part B payment limit or NADAC price is linked to this product.

Use it

Look up 63443-5057 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/63443-5057 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 63443-5057. 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.