FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
76045-235
11-digit product format
760450235
Labeler code
76045
Product ID
76045-235_5bfd2f08-2d90-47b1-9677-73c503e66956
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA091526
Marketing category
ANDA
Marketing start
2025-06-02
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
Rxcui1049289

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
76045-235-01Diphenhydramine Hydrochloride1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION113
76045-235-01Diphenhydramine Hydrochloride1 in 1 BLISTER PACKINJECTION, SOLUTION113
76045-235-10Diphenhydramine Hydrochloride24 in 1 CARTONINJECTION, SOLUTION2413

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]7
DiphenhydramineACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]7
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]7
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]7
WaterINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [BD RX INC.]7

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049289diphenhydrAMINE HCl 50 MG in 1 ML Prefilled SyringePSN6d1aa0e2-036d-4382-a458-fc0300dba7cb13
10492891 ML diphenhydramine hydrochloride 50 MG/ML Prefilled SyringeSCD6d1aa0e2-036d-4382-a458-fc0300dba7cb13
1049289diphenhydramine HCl 50 MG per 1 ML Prefilled SyringeSY6d1aa0e2-036d-4382-a458-fc0300dba7cb13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76045-235-01760450235011 mL in 1 SYRINGE, GLASS1 mlHistorical
76045-235-107604502351024 BLISTER PACK in 1 CARTON (76045-235-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-235-01) / 1 mL in 1 SYRINGE, GLASS24 blister pack2025-06-02NoNoHistorical