Diphenhydramine Hydrochloride

Product NDC
70385-2007
11-digit product format
703852007
Labeler code
70385
Product ID
70385-2007_8117f22a-3a26-c5a3-e053-2991aa0ac782
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sina Health 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
No
Listing certified through
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70385-2007-2Diphenhydramine Hydrochloride1 mL in 1 VIALINJECTION13
70385-2007-2Diphenhydramine Hydrochloride2 in 1 PACKAGEINJECTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70385-2007DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [SINA HEALTH INC]3Legacy NDC, 2 package rows20190205_2d51aae4-d1da-22bc-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN2d51aae4-d1da-22bc-e054-00144ff88e883
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD2d51aae4-d1da-22bc-e054-00144ff88e883
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY2d51aae4-d1da-22bc-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70385-2007-2703852007021 mL in 1 VIAL1 mlHistorical