Home NDC 70518-4536 Diphenhydramine Hydrochloride
Product NDC 70518-4536
11-digit product format 705184536
Labeler code 70518
Product ID 70518-4536_5b9bb683-aad5-9271-e063-6394a90a341d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler REMEDYREPACK INC.
Application ANDA205336
Marketing category ANDA
Marketing start 2025-12-18
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 2026-09-14 22:38:34 2026-08 A205336-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2025-06-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205336-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2025-06-24 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Diphenhydramine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4536-0 Diphenhydramine Hydrochloride 25 in 1 PACKAGE INJECTION 25 1 70518-4536-1 Diphenhydramine Hydrochloride 1 mL in 1 VIAL, GLASS INJECTION 1 1
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 · 3 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 70518-4536-0 70518453600 25 VIAL, GLASS in 1 PACKAGE (70518-4536-0) / 1 mL in 1 VIAL, GLASS (70518-4536-1) 2025-12-18 No No Current 70518-4536-1 70518453601 1 mL in 1 VIAL, GLASS 1 ml Historical