DailyMed label
Otezla
DailyMed label · Amgen, Inc · version 38
Key facts
| Product | Otezla |
|---|---|
| Labeler | Amgen, Inc |
| Document type | HUMAN PRESCRIPTION DRUG LABEL |
| Active ingredients | APREMILAST |
| Active ingredient UNIIs | UP7QBP99PN |
| Application number | 205437, 210745 |
| Route | ORAL |
| NDC package codes | 55513-137-60, 55513-137-95, 55513-369-55, 55513-485-95, 55513-485-96, 55513-497-60, 55513-508-55, 55513-996-96, 55513-996-95, 55513-519-30, 55513-516-41 |
| Effective date | Sep 2, 2026 |
| Set ID | f6b1f516-4972-4d82-bced-113e47b41cc5 |
At a glance
- 10–99 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: