Home NDC 55154-4743 Midazolam
Product NDC 55154-4743
11-digit product format 551544743
Labeler code 55154
Product ID 55154-4743_df3224fd-c165-4c9e-849f-f2ce135ca569
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MIDAZOLAM HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Cardinal Health 107, LLC
Application ANDA075857
Marketing category ANDA
Marketing start 2002-07-22
Substance MIDAZOLAM HYDROCHLORIDE
Active strength 1 mg/mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22
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 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075857-001 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075857-002 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2002-07-22 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Midazolam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIDAZOLAM HYDROCHLORIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W7TTW573JJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1666798 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 55154-4743-5 Midazolam 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 7 55154-4743-5 Midazolam 5 in 1 BAG INJECTION, SOLUTION 5 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-4743 MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240929_cbedf0bf-82a4-4214-96d5-01ac35e101f0.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MIDAZOLAM MIDAZOLAM HYDROCHLORIDE Hospira, Inc. b95415fa-17c2-42ab-a6b0-e628d01c94ed 2026-08-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075857 application number: ANDA075857 Midazolam MIDAZOLAM HYDROCHLORIDE Hospira, Inc. 1abda8b8-48a8-4995-af86-39220d1aa240 2026-08-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075857 application number: ANDA075857 Midazolam MIDAZOLAM HYDROCHLORIDE Cardinal Health 107, LLC cbedf0bf-82a4-4214-96d5-01ac35e101f0 2026-06-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075857 application number: ANDA075857 ndc (product): 55154-4743 Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE Henry Schein, Inc. 9e3bd5d3-36b3-471c-b8cc-ef48645700c2 2025-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075857 application number: ANDA075857
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55154-4743-5 55154474305 5 VIAL, SINGLE-DOSE in 1 BAG (55154-4743-5) / 2 mL in 1 VIAL, SINGLE-DOSE 2002-07-22 0000-00-00 No No Current