Quick answers
- What is Apomorphine hydrochloride used for?
- The FDA-approved label (Apomorphine Hydrocloride, TruPharma, LLC, February 24, 2022) says: “Apomorphine hydrochloride injection is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced Parkinson's disease. Apomorphine hydrocloride inejction has been studied as an adjunct to other medications […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Apomorphine hydrochloride have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Apomorphine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Apomorphine hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Apomorphine hydrochloride?
- 3 companies list prescription products of Apomorphine hydrochloride in the FDA NDC Directory, including MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc., TruPharma, LLC and MDD US Operations, LLC.
What Apomorphine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Apomorphine hydrochloride injection is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced Parkinson's disease. Apomorphine hydrocloride inejction has been studied as an adjunct to other medications […]. …
— FDA label: Apomorphine Hydrocloride, TruPharma, LLC, effective February 24, 2022. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.1 product
- TruPharma, LLC1 product
- MDD US Operations, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021264 APOKYN | Mdd Us | April 20, 2004 | 11, latest February 3, 2025 2025: Manufacturing (CMC) · 2022: Labeling · 2022: Labeling |
| NDA214056 ONAPGO | Mdd Us | February 3, 2025 | 2, latest June 30, 2026 2026: Labeling · 2026: Labeling |
Generic approvals (1)
- ANDA212025Tp Anda Holdings · February 23, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 855856 |
|---|---|
| SPL set ID of the quoted label | aedf70e4-1949-44bc-bf1b-0f282c4f0705 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA021264, NDA214056, 1 ANDA |
| Active ingredients (FDA) | APOMORPHINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Apomorphine Hydrocloride, TruPharma, LLC, effective February 24, 2022; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →