FDA.reportPublic FDA data

APOKYN

Product NDC
27505-004
11-digit product format
275050004
Labeler code
27505
Product ID
27505-004_41c194a6-daa8-f307-e063-6394a90ade0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
APOMORPHINE HYDROCHLORIDE
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
MDD US Operations, LLC
Application
NDA021264
Marketing category
NDA
Marketing start
2004-07-02
Substance
APOMORPHINE HYDROCHLORIDE
Active strength
30 mg/3mL
Pharmacologic classes
Dopamine Agonists [MoA], Dopaminergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
APOKYN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APOMORPHINE HYDROCHLORIDE30 mg/3mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8cacec2b-1363-4e94-885c-4189d5e7208aProduct name120251117
d7fea1a2-3459-27e8-1231-1b79988f4937Product name220221207
3a53909e-cbfb-4956-984e-a33101906fd9Product name120201021
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27505-004-01APOKYN3 mL in 1 CARTRIDGEINJECTION321
27505-004-05APOKYN5 in 1 CARTONINJECTION521

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27505-004-01ML - Milliliter27505-004069cd00a-7f9d-4449-bb10-827d5e0bc62112012-07-24
27505-004-05ML - Milliliter27505-0042ff3ccc6-8234-4336-a911-cd8f5a43774e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
APOMORPHINE HYDROCHLORIDEACTIVE INGREDIENTF39049Y068APOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]4
APOMORPHINEACTIVE MOIETYN21FAR7B4SAPOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]4
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHAPOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]4
hydrochloric acidINACTIVE INGREDIENTQTT17582CBAPOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32IAPOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]4
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CAPOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]4
waterINACTIVE INGREDIENT059QF0KO0RAPOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [US WORLDMEDS, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27505-004APOKYN (APOMORPHINE HYDROCHLORIDE) INJECTION [MDD US OPERATIONS, LLC]21Current NDC, Legacy NDC, 2 package rows20241012_3235535d-9ef9-4657-8b2a-176a807d091c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855858Apokyn 30 MG in 3 mL CartridgePSN3235535d-9ef9-4657-8b2a-176a807d091c21
855856apomorphine HCl 30 MG in 3 mL CartridgePSN3235535d-9ef9-4657-8b2a-176a807d091c21
8558583 ML apomorphine hydrochloride 10 MG/ML Cartridge [Apokyn]SBD3235535d-9ef9-4657-8b2a-176a807d091c21
8558563 ML apomorphine hydrochloride 10 MG/ML CartridgeSCD3235535d-9ef9-4657-8b2a-176a807d091c21
8558583 ML Apokyn 10 MG/ML CartridgeSY3235535d-9ef9-4657-8b2a-176a807d091c21
855858Apokyn 30 MG per 3 ML CartridgeSY3235535d-9ef9-4657-8b2a-176a807d091c21
855856apomorphine HCl 30 MG per 3 ML CartridgeSY3235535d-9ef9-4657-8b2a-176a807d091c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27505-004-01275050004013 mL in 1 CARTRIDGE3 mlHistorical
27505-004-05275050004055 CARTRIDGE in 1 CARTON (27505-004-05) / 3 mL in 1 CARTRIDGE (27505-004-01) 5 cartridge2004-07-020000-00-00NoNoCurrent