DailyMed label
CONCERTA
DailyMed label · Janssen Pharmaceuticals, Inc. · version 30
Key facts
| Product | CONCERTA |
|---|---|
| Labeler | Janssen Pharmaceuticals, Inc. |
| Document type | HUMAN PRESCRIPTION DRUG LABEL |
| Active ingredients | METHYLPHENIDATE HYDROCHLORIDE |
| Active ingredient UNIIs | 4B3SC438HI |
| Application number | 021121 |
| Route | ORAL |
| DEA schedule | CII |
| NDC package codes | 50458-585-01, 50458-588-01, 50458-586-01, 50458-587-01 |
| Effective date | Apr 20, 2026 |
| Set ID | 1a88218c-5b18-4220-8f56-526de1a276cd |
At a glance
- 1–9 NDC package codes
- 1–9 Active ingredients
- 1–9 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: