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NDC 27505-0004-05 APOKYN 30 mg/3mL Details
APOKYN 30 mg/3mL
APOKYN is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by MDD US Operations, LLC. The primary component is APOMORPHINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Apomorphine injection is used to treat ''off'' episodes (times of difficulty moving, walking, and speaking that may happen as medication wears off or at random) in people with advanced Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) who are taking other medications for their condition. Apomorphine injection is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance produced in the brain that is needed to control movement.
Related Packages: 27505-0004-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Apomorphine Injection
Product Information
| NDC | 27505-0004 |
|---|---|
| Product ID | 27505-004_0cf4a4b6-9e6b-dc85-e063-6394a90a2762 |
| Associated GPIs | |
| GCN Sequence Number | 044660 |
| GCN Sequence Number Description | apomorphine HCl CARTRIDGE 10 MG/ML SUBCUT |
| HIC3 | H6A |
| HIC3 Description | ANTIPARKINSONISM DRUGS,OTHER |
| GCN | 42078 |
| HICL Sequence Number | 001934 |
| HICL Sequence Number Description | APOMORPHINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | APOKYN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | APOMORPHINE HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/3mL |
| Substance Name | APOMORPHINE HYDROCHLORIDE |
| Labeler Name | MDD US Operations, LLC |
| Pharmaceutical Class | Dopamine Agonists [MoA], Dopaminergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021264 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 27505-0004-05 (27505000405)
| NDC Package Code | 27505-004-05 |
|---|---|
| Billing NDC | 27505000405 |
| Package | 5 CARTRIDGE in 1 CARTON (27505-004-05) / 3 mL in 1 CARTRIDGE (27505-004-01) |
| Marketing Start Date | 2004-07-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |