Home NDC 0409-1985-30 Lorazepam
Product NDC 0409-1985
Requested package NDC 0409-1985-30
11-digit product format 004091985
Labeler code 0409
Product ID 0409-1985_0280cc35-0696-4091-a000-2314f292feb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LORAZEPAM
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA074243
Marketing category ANDA
Marketing start 2005-06-06
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 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 A074243-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 1994-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074243-002 LORAZEPAM 4MG/ML INJECTABLE / INJECTION AP 1994-04-12 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 85 observed states.
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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 763028 Internal RxNorm lookup 763029 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 0409-1985-03 Lorazepam 1 mL in 1 CARTRIDGE INJECTION, SOLUTION 1 27 0409-1985-30 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 LORAZEPAM ACTIVE INGREDIENT O26FZP769L LORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 LORAZEPAM ACTIVE MOIETY O26FZP769L LORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH LORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A LORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1985 LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.] 27 Current NDC, 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 0409-1985-30 00409198530 10 CARTRIDGE in 1 CARTON (0409-1985-30) / 1 mL in 1 CARTRIDGE (0409-1985-03) 10 cartridge 2005-06-06 0000-00-00 No No Current