Home NDC 0404-9916 Midazolam Hydrochloride
Product NDC 0404-9916
11-digit product format 004049916
Labeler code 0404
Product ID 0404-9916_cf4854ec-c2d6-486d-9712-ffe9dac99926
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Midazolam Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA075857
Marketing category ANDA
Marketing start 2022-01-17
Substance MIDAZOLAM HYDROCHLORIDE
Active strength 5 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 Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIDAZOLAM HYDROCHLORIDE 5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1666814 Internal RxNorm lookup 1666823 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 0404-9916-01 Midazolam Hydrochloride 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 6 0404-9916-01 Midazolam Hydrochloride 1 in 1 BAG INJECTION, SOLUTION 1 6 0404-9916-02 Midazolam Hydrochloride 1 in 1 BAG INJECTION, SOLUTION 1 6 0404-9916-02 Midazolam Hydrochloride 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9916 MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.] 5 Current NDC, Legacy NDC, 4 package rows 20250326_9e3bd5d3-36b3-471c-b8cc-ef48645700c2.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 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 ndc (product): 0404-9916
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 0404-9916-01 00404991601 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-01) / 1 mL in 1 VIAL, SINGLE-DOSE 2022-01-17 0000-00-00 No No Current 0404-9916-02 00404991602 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-02) / 2 mL in 1 VIAL, SINGLE-DOSE 2022-01-17 0000-00-00 No No Current