DailyMed label

Methylphenidate

DailyMed label · Sandoz Inc · version 4

Key facts

Product Methylphenidate
Labeler Sandoz Inc
Document type HUMAN PRESCRIPTION DRUG LABEL
Active ingredients METHYLPHENIDATE HYDROCHLORIDE
Active ingredient UNIIs 4B3SC438HI
Application number NDA021284
Route ORAL
DEA schedule CII
NDC package codes 0781-2384-01, 0781-2385-01, 0781-2386-01, 0781-2383-01
Effective date Sep 23, 2025
Set ID 44386394-d2a3-4483-abe1-6c5c634cc501

At a glance

  • 1–9 NDC package codes
  • 1–9 Active ingredients
  • None Manufacturing establishments listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About DailyMed drug labels

DailyMed publishes the structured product labeling (SPL) that companies submit to the FDA, including package NDCs, ingredients and the establishments that make each product.

Source: U.S. National Library of Medicine (NLM), DailyMed · Source date:

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