Diphenhydramine Hydrochloride

Product NDC
71872-7180
11-digit product format
718727180
Labeler code
71872
Product ID
71872-7180_fa40e1b9-15f4-2324-e053-6394a90a66ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA205723
Marketing category
ANDA
Marketing start
2019-05-01
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
71872-7180-1Diphenhydramine Hydrochloride1 in 1 BAGINJECTION, SOLUTION12
71872-7180-1Diphenhydramine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7180DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230427_95fbf4c2-c96e-2d41-e053-2995a90a0d54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN95fbf4c2-c96e-2d41-e053-2995a90a0d542
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD95fbf4c2-c96e-2d41-e053-2995a90a0d542
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY95fbf4c2-c96e-2d41-e053-2995a90a0d542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7180-1718727180011 VIAL, SINGLE-DOSE in 1 BAG (71872-7180-1) / 1 mL in 1 VIAL, SINGLE-DOSE2019-10-090000-00-00NoNoCurrent