DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC
51662-1374
11-digit product format
516621374
Labeler code
51662
Product ID
51662-1374_52312227-1f3c-9b33-e063-6294a90aff86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA040466
Marketing category
ANDA
Marketing start
2019-11-11
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
51662-1374-1DIPHENHYDRAMINE HYDROCHLORIDE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1374DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 1 package rows20210303_9713d8ee-6ab2-2fdf-e053-2a95a90a9e19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN9713d8ee-6ab2-2fdf-e053-2a95a90a9e194
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD9713d8ee-6ab2-2fdf-e053-2a95a90a9e194
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY9713d8ee-6ab2-2fdf-e053-2a95a90a9e194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1374-1516621374011 mL in 1 VIAL, SINGLE-DOSE (51662-1374-1) 1 ml2019-11-110000-00-00NoNoCurrent