Diphenhydramine Hydrochloride

Product NDC
52584-664
11-digit product format
525840664
Labeler code
52584
Product ID
52584-664_7f1fdfde-c444-4290-a2e6-46b49e8f6580
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc
Application
ANDA040466
Marketing category
ANDA
Marketing start
2017-06-13
Marketing end
2021-02-28
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-664-01525840664011 VIAL in 1 BAG (52584-664-01) > 1 mL in 1 VIAL1 vial2017-06-132021-02-28NoNoCurrent