Home NDC 83634-781 Diphenhydramine
Product NDC 83634-781
11-digit product format 836340781
Labeler code 83634
Product ID 83634-781_908025cf-e126-4241-b794-47d2fd90078e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diphenhydramine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Avenacy, LLC
Application ANDA205336
Marketing category ANDA
Marketing start 2025-09-01
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205336-001 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2025-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205336-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A205336-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2025-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205336-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2025-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205336-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2025-06-24 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205336-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2025-06-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A205336-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205336-001 AP 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205336-001 AP 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205336-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Diphenhydramine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1723740 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83634-781-01 Diphenhydramine 25 in 1 CARTON INJECTION, SOLUTION 25 4 83634-781-41 Diphenhydramine 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 4
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83634-781-01 83634078101 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-781-01) / 1 mL in 1 VIAL, SINGLE-DOSE (83634-781-41) 2025-09-01 No No Current 83634-781-41 83634078141 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical