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Focalin XR

NDC 0078-0433, dexmethylphenidate hydrochloride, capsule, extended release, from Novartis Pharmaceuticals Corporation.

Product NDC
0078-0433
Status
Listed
Labeler
Novartis Pharmaceuticals Corporation
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
NDA
Application
NDA021802
DEA schedule
CII
Request
curl https://api.healthcare.dev/v1/drugs/ndc/0078-0433 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • DEXMETHYLPHENIDATE HYDROCHLORIDE30 mg/1

Pharmacologic classes

Central Nervous System Stimulant [EPC]; Central Nervous System Stimulation [PE]

Package NDCNDC-11Package
0078-0433-0500078043305100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0433-05)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/1a1da905-42a0-4748-9c39-67eca45deccc

  • NADAC price for package 00078043305

    GET /v1/drugs/nadac/00078043305

Use it

Look up 0078-0433 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/0078-0433 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 0078-0433. 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.