apomorphine hydrocloride

Product NDC
52817-720
11-digit product format
528170720
Labeler code
52817
Product ID
52817-720_2fbd7414-f94f-4e18-8d0e-3ae69a5449f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
APOMORPHINE HYDROCHLORIDE
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
TruPharma, LLC
Application
ANDA212025
Marketing category
ANDA
Marketing start
2022-02-24
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
apomorphine hydrocloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APOMORPHINE HYDROCHLORIDE30 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF39049Y068
Rxcui855856

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52817-720-01apomorphine hydrocloride3 mL in 1 CARTRIDGEINJECTION31
52817-720-05apomorphine hydrocloride5 in 1 CARTONINJECTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-720-01ML - Milliliter52817-720d44b4ba3-5faf-4db9-97e2-8889ef8b37dc12022-03-09
52817-720-05ML - Milliliter52817-720c4ace5b2-bf2d-498c-bfbd-1ed7d02a32b212022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-720APOMORPHINE HYDROCLORIDE (APOMORPHINE HYDROCHLORIDE) INJECTION [TRUPHARMA, LLC]1Current NDC, Legacy NDC, 2 package rows20220226_aedf70e4-1949-44bc-bf1b-0f282c4f0705.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855856apomorphine HCl 30 MG in 3 mL CartridgePSNaedf70e4-1949-44bc-bf1b-0f282c4f07051
8558563 ML apomorphine hydrochloride 10 MG/ML CartridgeSCDaedf70e4-1949-44bc-bf1b-0f282c4f07051
855856apomorphine HCl 30 MG per 3 ML CartridgeSYaedf70e4-1949-44bc-bf1b-0f282c4f07051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-720-01528170720013 mL in 1 CARTRIDGE3 mlHistorical
52817-720-05528170720055 CARTRIDGE in 1 CARTON (52817-720-05) / 3 mL in 1 CARTRIDGE (52817-720-01) 5 cartridge2022-02-240000-00-00NoNoCurrent