Diphenhydramine Hydrochloride

Product NDC
71872-7373
11-digit product format
718727373
Labeler code
71872
Product ID
71872-7373_51bb1ca2-32ef-4840-e063-6394a90a6faa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
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
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 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
71872-7373-1Diphenhydramine Hydrochloride1 in 1 BAGINJECTION11
71872-7373-1Diphenhydramine Hydrochloride1 mL in 1 VIAL, GLASSINJECTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN51bb483f-3fe6-8a94-e063-6394a90acf7d1
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD51bb483f-3fe6-8a94-e063-6394a90acf7d1
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY51bb483f-3fe6-8a94-e063-6394a90acf7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71872-7373-1718727373011 VIAL, GLASS in 1 BAG (71872-7373-1) / 1 mL in 1 VIAL, GLASS2026-05-13NoNoCurrent