Home NDC 68083-611-25 Diphenhydramine Hydrochloride
Product NDC 68083-611
Requested package NDC 68083-611-25
11-digit product format 680830611
Labeler code 68083
Product ID 68083-611_89f09a33-2535-47c9-8942-dd8ebe5d3b4a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA218448
Marketing category ANDA
Marketing start 2024-03-20
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 44 .
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 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218448-001 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 2026-10-15 13:18:30 2026-09 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218448-001 DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2024-03-20 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
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 68083-611-25 Diphenhydramine Hydrochloride 1 mL in 1 VIAL INJECTION 1 2 68083-611-25 Diphenhydramine Hydrochloride 25 in 1 CARTON INJECTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-611 DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [GLAND PHARMA LIMITED] 2 Current NDC, 2 package rows 20240323_eeb70724-065c-4a73-8e2e-d6b2a625e8d4.zip
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 · 2 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 68083-611-25 68083061125 25 VIAL in 1 CARTON (68083-611-25) / 1 mL in 1 VIAL 25 vial 2024-03-20 No No Current