Home NDC 0409-1539-31 Lorazepam
Product NDC 0409-1539
Requested package NDC 0409-1539-31
11-digit product format 004091539
Labeler code 0409
Product ID 0409-1539_609d01a8-9c20-4e9a-a77f-527dc4487f9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LORAZEPAM
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA074243
Marketing category ANDA
Marketing start 2005-12-28
Marketing end 0000-00-00
Substance LORAZEPAM
Active strength 4 mg/mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074243-001 LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 A074243-002 LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 84 observed 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 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 83 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-1539-03 Lorazepam 1 mL in 1 CARTRIDGE INJECTION, SOLUTION 1 27 0409-1539-31 Lorazepam 10 in 1 CARTON INJECTION, SOLUTION 10 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LORAZEPAM ACTIVE INGREDIENT O26FZP769L LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 11 LORAZEPAM ACTIVE MOIETY O26FZP769L LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 11 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 11 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1539 LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 27 Legacy NDC, 2 package rows 20231030_20140b19-846b-425f-b191-670e17809945.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 Marketing end Sample Exclude flag Status 0409-1539-31 00409153931 10 CARTRIDGE in 1 CARTON (0409-1539-31) > 1 mL in 1 CARTRIDGE (0409-1539-03) 10 cartridge 2005-12-28 0000-00-00 No No Current