Diphenhydramine Hydrochloride

Product NDC
64725-0376
11-digit product format
647250376
Labeler code
64725
Product ID
64725-0376_ee7a0577-37b2-4747-b7c4-64cb7e74000e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
TYA Pharmaceuticals
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
64725-0376-12020-01-31C16284748780-19d75b9d0-9181-f424-e053-dadaa90a57ceDiphenhydramine Hydrochloride Injection, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0376-1Diphenhydramine Hydrochloride25 mL in 1 PACKAGEINJECTION252

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0376DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141110_2a924d55-3ad6-4efe-88a6-803249bc9900.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN2a924d55-3ad6-4efe-88a6-803249bc99002
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD2a924d55-3ad6-4efe-88a6-803249bc99002
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY2a924d55-3ad6-4efe-88a6-803249bc99002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64725-0376-16472503760125 mL in 1 PACKAGE25 mlHistorical