FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
50090-0878
11-digit product format
500900878
Labeler code
50090
Product ID
50090-0878_3e351041-092e-4928-afd5-798f66c4dc9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA080817
Marketing category
ANDA
Marketing start
1972-11-27
Substance
DIPHENHYDRAMINE HCL
Active strength
50 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HCL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049633

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
50090-0878-02023-02-06C16284748780-1f386c649-c9f6-0266-e053-dadaa90a7c1aDiphenhydramine Hydrochloride Injection, USP Rx only
50090-0878-02023-01-30C16284748780-1f386c649-c9f6-0266-e053-dadaa90a7c1aDiphenhydramine Hydrochloride Injection, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0878-0Diphenhydramine Hydrochloride1 in 1 CARTONINJECTION16
50090-0878-0Diphenhydramine Hydrochloride50 mL in 1 VIALINJECTION506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0878-0ML - Milliliter50090-0878b5064197-a96b-4726-b8e7-137560716d9712021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0878DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20230208_eedb421c-0020-4e5f-8b09-26a1cbabb681.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNeedb421c-0020-4e5f-8b09-26a1cbabb6816
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDeedb421c-0020-4e5f-8b09-26a1cbabb6816
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYeedb421c-0020-4e5f-8b09-26a1cbabb6816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0878-0500900878001 VIAL in 1 CARTON (50090-0878-0) / 50 mL in 1 VIAL1 vial2014-11-280000-00-00NoNoCurrent