Home NDC 0404-9912-10 Midazolam
Product NDC 0404-9912
Requested package NDC 0404-9912-10
11-digit product format 004049912
Labeler code 0404
Product ID 0404-9912_445f7470-be78-446f-80db-b239ee38d33e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Midazolam
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA075154
Marketing category ANDA
Marketing start 2022-01-13
Marketing end 0000-00-00
Substance MIDAZOLAM HYDROCHLORIDE
Active strength 1 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 · 6 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…
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 A075154-001 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 A075154-002 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20
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 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Midazolam MIDAZOLAM HYDROCHLORIDE Fresenius Kabi USA, LLC a91ce254-14a3-4cbf-8ab8-5da252aa3fdc 2024-07-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075154 application number: ANDA075154
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0404-9912-10 00404991210 1 VIAL in 1 BAG (0404-9912-10) > 10 mL in 1 VIAL 1 vial 2022-01-13 0000-00-00 No No Current