NDC directory

Dexmethylphenidate Hydrochloride Extended-Release

dexmethylphenidate hydrochloride · Sandoz Inc · CAPSULE, EXTENDED RELEASE

0781-2734NDA AUTHORIZED GENERICCentral Nervous System Stimulant [EPC]
Product NDC
0781-2734
Generic name
dexmethylphenidate hydrochloride
Labeler name
Sandoz Inc
Dea schedule
CII
Brand name
Dexmethylphenidate Hydrochloride Extended-Release
Brand name suffix
Extended-Release
Finished
true
Listing expiration date
20271231
Marketing category
NDA AUTHORIZED GENERIC
Dosage form
CAPSULE, EXTENDED RELEASE
SPL ID
71f56227-d87a-4bc0-a879-c1993c6ccba6
Product type
HUMAN PRESCRIPTION DRUG
Marketing start date
20261001
Product ID
0781-2734_71f56227-d87a-4bc0-a879-c1993c6ccba6
Application number
NDA021802
Brand name base
Dexmethylphenidate Hydrochloride
Active ingredients
  1. Name
    DEXMETHYLPHENIDATE HYDROCHLORIDE
    Strength
    40 mg/1
Packaging
  1. Package NDC
    0781-2734-31
    Description
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2734-31)
    Marketing start date
    20261001
    Sample
    false
Route
ORAL
Pharm class
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.