Diphenhydramine Hydrochloride

Product NDC
50090-1841
11-digit product format
500901841
Labeler code
50090
Product ID
50090-1841_8d155a86-c841-435e-9452-e1262e598072
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1841-0Diphenhydramine Hydrochloride25 in 1 PACKAGEINJECTION2516
50090-1841-0Diphenhydramine Hydrochloride1 mL in 1 VIALINJECTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1841-0ML - Milliliter50090-1841dc8999f3-51f5-498c-965b-0dbd32e77e3312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1841DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 2 package rows20240214_5af966ae-535b-492b-ba2c-eeb4e40be959.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSN5af966ae-535b-492b-ba2c-eeb4e40be95916
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCD5af966ae-535b-492b-ba2c-eeb4e40be95916
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSY5af966ae-535b-492b-ba2c-eeb4e40be95916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1841-05009018410025 VIAL in 1 PACKAGE (50090-1841-0) / 1 mL in 1 VIAL25 vial2015-05-210000-00-00NoNoCurrent