FDA.reportPublic FDA data

DIPHENHYDRAMINE

Product NDC
42571-337
11-digit product format
425710337
Labeler code
42571
Product ID
42571-337_4c46492b-00c4-8ee4-e063-6294a90a6914
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Micro Labs Limited
Application
ANDA205723
Marketing category
ANDA
Marketing start
2019-12-10
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
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
42571-337-56DIPHENHYDRAMINE1 in 1 CARTONINJECTION, SOLUTION111
42571-337-56DIPHENHYDRAMINE1 mL in 1 VIALINJECTION, SOLUTION111
42571-337-78DIPHENHYDRAMINE1 mL in 1 VIALINJECTION, SOLUTION111
42571-337-78DIPHENHYDRAMINE5 in 1 CARTONINJECTION, SOLUTION511
42571-337-87DIPHENHYDRAMINE25 in 1 CARTONINJECTION, SOLUTION2511
42571-337-95DIPHENHYDRAMINE1 mL in 1 VIALINJECTION, SOLUTION111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-337DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) INJECTION, SOLUTION [MICRO LABS LIMITED]9Current NDC, Legacy NDC, 6 package rows20221129_a1110433-498a-48cb-ac79-5732fd4f8fba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSNa1110433-498a-48cb-ac79-5732fd4f8fba11
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCDa1110433-498a-48cb-ac79-5732fd4f8fba11
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSYa1110433-498a-48cb-ac79-5732fd4f8fba11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-337-56425710337561 VIAL in 1 CARTON (42571-337-56) / 1 mL in 1 VIAL1 vial2026-03-05NoNoHistorical
42571-337-78425710337785 VIAL in 1 CARTON (42571-337-78) / 1 mL in 1 VIAL5 vial2026-03-03NoNoHistorical
42571-337-874257103378725 VIAL in 1 CARTON (42571-337-87) / 1 mL in 1 VIAL (42571-337-95) 25 vial2019-12-100000-00-00NoNoCurrent
42571-337-95425710337951 mL in 1 VIAL1 mlHistorical