Home NDC 65219-368 Lorazepam
Product NDC 65219-368
11-digit product format 652190368
Labeler code 65219
Product ID 65219-368_462a13da-259a-40e7-bd5b-f7f42ae025b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lorazepam
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA217598
Marketing category ANDA
Marketing start 2024-12-13
Substance LORAZEPAM
Active strength 2 mg/mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
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 42 .
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 A217598-001 LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2024-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217598-001 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 2026-08-18 06:07:40 2026-07 A217598-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2024-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217598-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2024-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217598-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2024-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217598-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2024-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217598-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2024-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217598-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2024-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217598-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2024-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217598-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2024-11-18 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217598-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2024-11-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lorazepam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORAZEPAM 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O26FZP769L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665188 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 65219-368-01 Lorazepam 1 mL in 1 VIAL INJECTION 1 1 65219-368-02 Lorazepam 25 in 1 TRAY INJECTION 25 1 65219-368-14 Lorazepam 1 mL in 1 VIAL INJECTION 1 1 65219-368-24 Lorazepam 25 in 1 TRAY INJECTION 25 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-368 LORAZEPAM INJECTION [FRESENIUS KABI USA, LLC] 1 Current NDC, 2 package rows 20241213_b2487467-a63f-48b5-b0de-3a6ce6672d50.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 65219-368-01 65219036801 1 mL in 1 VIAL 1 ml Historical 65219-368-02 65219036802 25 VIAL in 1 TRAY (65219-368-02) / 1 mL in 1 VIAL (65219-368-01) 25 vial 2024-12-13 No No Current 65219-368-14 65219036814 1 mL in 1 VIAL 1 ml Historical 65219-368-24 65219036824 25 VIAL in 1 TRAY (65219-368-24) / 1 mL in 1 VIAL (65219-368-14) 25 vial 2024-12-13 No No Current