DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC
51662-1219
11-digit product format
516621219
Labeler code
51662
Product ID
51662-1219_11ffb76f-6e96-cf3c-e063-6294a90aa8df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co. LLC, DBA Health First
Application
ANDA080817
Marketing category
ANDA
Marketing start
2018-08-16
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1219-1DIPHENHYDRAMINE HYDROCHLORIDE1 mL in 1 VIALINJECTION17
51662-1219-2DIPHENHYDRAMINE HYDROCHLORIDE1 mL in 1 POUCHINJECTION17
51662-1219-3DIPHENHYDRAMINE HYDROCHLORIDE25 in 1 CASEINJECTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1219DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [HF ACQUISITION CO. LLC, DBA HEALTH FIRST]7Current NDC, Legacy NDC, 3 package rows20240224_738f2ce3-520c-b3a2-e053-2a91aa0af324.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN738f2ce3-520c-b3a2-e053-2a91aa0af3247
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD738f2ce3-520c-b3a2-e053-2a91aa0af3247
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY738f2ce3-520c-b3a2-e053-2a91aa0af3247

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1219-1516621219011 mL in 1 VIAL (51662-1219-1) 1 ml2018-08-160000-00-00NoNoCurrent
51662-1219-2516621219021 mL in 1 POUCH1 mlHistorical
51662-1219-35166212190325 POUCH in 1 CASE (51662-1219-3) / 1 mL in 1 POUCH (51662-1219-2) 25 pouch2020-06-150000-00-00NoNoCurrent