Diphenhydramine Hydrochloride

Product NDC
23155-264
11-digit product format
231550264
Labeler code
23155
Product ID
23155-264_94dd89a8-b3cd-45cf-abdd-ff383e3a24d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA205336
Marketing category
ANDA
Marketing start
2025-06-30
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1723740

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-264-31Diphenhydramine Hydrochloride1 mL in 1 VIAL, GLASSINJECTION16
23155-264-41Diphenhydramine Hydrochloride25 in 1 PACKAGEINJECTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-264-31ML - Milliliter23155-2649ea68365-c2b4-49c1-bba5-617e4893aa5c12025-09-12
23155-264-41ML - Milliliter23155-264ecb47f38-1a3e-4da9-ad45-c1c70021839812025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN483fbd4c-25c7-4553-8c3f-089daca84ae66
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD483fbd4c-25c7-4553-8c3f-089daca84ae66
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY483fbd4c-25c7-4553-8c3f-089daca84ae66
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN51bb483f-3fe6-8a94-e063-6394a90acf7d1
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN5bbbd6e5-4d0a-4380-bbd3-3313ff26cda01
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD51bb483f-3fe6-8a94-e063-6394a90acf7d1
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD5bbbd6e5-4d0a-4380-bbd3-3313ff26cda01
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY51bb483f-3fe6-8a94-e063-6394a90acf7d1
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY5bbbd6e5-4d0a-4380-bbd3-3313ff26cda01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-264-31231550264311 mL in 1 VIAL, GLASS1 mlHistorical
23155-264-412315502644125 VIAL, GLASS in 1 PACKAGE (23155-264-41) / 1 mL in 1 VIAL, GLASS (23155-264-31) 2025-06-30NoNoCurrent