Diphenhydramine Hydrochloride

Product NDC
55045-3683
11-digit product format
550453683
Labeler code
55045
Product ID
55045-3683_c1d3f51d-5d58-4d4e-9f7c-81e0734822b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Dispensing Solutions, Inc.
Application
ANDA080817
Marketing category
ANDA
Marketing start
1972-11-27
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55045-3683-12019-11-13C16284748780-197449f38-d325-f6ea-e053-dbdaa90aa703Diphenhydramine Hydrochloride Injection, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55045-3683-1Diphenhydramine Hydrochloride1 mL in 1 VIALINJECTION12
55045-3683-1Diphenhydramine Hydrochloride25 in 1 PACKAGEINJECTION252

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55045-3683DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 2 package rows20111013_4c40fb96-819a-4e11-9500-f11cbd51fd6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN4c40fb96-819a-4e11-9500-f11cbd51fd6c2
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD4c40fb96-819a-4e11-9500-f11cbd51fd6c2
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY4c40fb96-819a-4e11-9500-f11cbd51fd6c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55045-3683-1550453683011 mL in 1 VIAL1 mlHistorical