Diphenhydramine Hydrochloride

Product NDC
67457-124
11-digit product format
674570124
Labeler code
67457
Product ID
67457-124_0430e5e0-3024-42f5-9c97-073a5d71fb3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA040498
Marketing category
ANDA
Marketing start
2013-05-09
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-124-10ML - Milliliter67457-124855c6c71-5052-4638-9b2a-a93bbeb6167012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-124DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]10Legacy NDC20250104_82cd7a3c-acd6-44dc-8c95-f066162a510c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-124-10674570124101 VIAL, GLASS in 1 CARTON (67457-124-10) > 10 mL in 1 VIAL, GLASS2013-05-090000-00-00NoNoCurrent