FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
70518-1082
11-digit product format
705181082
Labeler code
70518
Product ID
70518-1082_485992c3-e3e0-e79a-e063-6294a90a655b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA080817
Marketing category
ANDA
Marketing start
2018-03-27
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
Rxcui1049633

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1082-12023-03-06C16284748780-1f386c64a-44b3-0266-e053-dadaa90a7c1aDiphenhydramine Hydrochloride Injection, USP Rx only
70518-1082-12023-01-30C16284748780-1f386c64a-44b3-0266-e053-dadaa90a7c1aDiphenhydramine Hydrochloride Injection, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1082-0Diphenhydramine Hydrochloride1 mL in 1 VIALINJECTION116
70518-1082-1Diphenhydramine Hydrochloride25 in 1 PACKAGEINJECTION2516

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1082DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 2 package rows20250522_62edde3d-b41b-40fc-ac18-b749035de831.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSN62edde3d-b41b-40fc-ac18-b749035de83116
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCD62edde3d-b41b-40fc-ac18-b749035de83116
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSY62edde3d-b41b-40fc-ac18-b749035de83116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1082-0705181082001 mL in 1 VIAL1 mlHistorical
70518-1082-17051810820125 VIAL in 1 PACKAGE (70518-1082-1) / 1 mL in 1 VIAL (70518-1082-0) 25 vial2018-03-270000-00-00NoNoCurrent