Diphenhydramine Hydrochloride

Product NDC
52584-376
11-digit product format
525840376
Labeler code
52584
Product ID
52584-376_04fb8ca4-1465-4ba1-92f9-22db184f6f64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables & Vaccines, Inc
Application
ANDA080817
Marketing category
ANDA
Marketing start
2010-07-01
Marketing end
2024-03-31
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-376-21525840376211 VIAL, SINGLE-DOSE in 1 BAG (52584-376-21) > 1 mL in 1 VIAL, SINGLE-DOSE2010-07-012024-03-31NoNoCurrent