Midazolam

Product NDC
50090-0683
Requested package NDC
50090-0683-1
11-digit product format
500900683
Labeler code
50090
Product ID
50090-0683_1422b2a8-41a8-449d-8f39-604333f6a4f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA075243
Marketing category
ANDA
Marketing start
2000-06-20
Marketing end
0000-00-00
Substance
MIDAZOLAM HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-068350090-0683-1DDiscontinued by firm2026-08-17

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075243-001MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20
A075243-002MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075243-001AP
A075243-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075243-001MIDAZOLAM HYDROCHLORIDEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075243-002MIDAZOLAM HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2000-06-20bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075243-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A075243-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075243-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075243-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075243-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075243-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075243-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075243-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075243-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075243-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075243-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075243-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075243-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075243-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075243-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075243-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075243-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075243-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075243-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075243-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075243-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075243-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075243-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075243-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075243-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075243-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075243-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075243-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075243-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075243-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075243-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075243-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075243-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075243-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075243-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075243-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075243-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075243-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075243-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075243-002AP1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-0683-02023-02-07Midazolam Injection, USP
50090-0683-12023-02-07Midazolam Injection, USP
50090-0683-02023-01-30Midazolam Injection, USP
50090-0683-12023-01-30Midazolam Injection, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0683-0ML - Milliliter50090-068376506a78-7349-4283-a355-55417b78320812018-10-11
50090-0683-1ML - Milliliter50090-0683527fd625-f545-4b79-b06f-de56ed39ff0c12018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM INJECTION [A-S MEDICATION SOLUTIONS LLC]1
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM INJECTION [A-S MEDICATION SOLUTIONS LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMIDAZOLAM INJECTION [A-S MEDICATION SOLUTIONS LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM INJECTION [A-S MEDICATION SOLUTIONS LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM INJECTION [A-S MEDICATION SOLUTIONS LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM INJECTION [A-S MEDICATION SOLUTIONS LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIDAZOLAM INJECTION [A-S MEDICATION SOLUTIONS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RMIDAZOLAM INJECTION [A-S MEDICATION SOLUTIONS LLC]1

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MidazolamMIDAZOLAMHenry Schein, Inc.3c2fd6ee-4ede-4ee4-8c05-34c93598f3812025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075243
application number: ANDA075243
MidazolamMIDAZOLAMHenry Schein, Inc.78e28b13-414e-4c34-a42c-caf1c3ba1f542025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075243
application number: ANDA075243
MidazolamMIDAZOLAMHenry Schein, Inc.94e1342b-f597-44c0-b8fc-b753fde04cbe2025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075243
application number: ANDA075243
MidazolamMIDAZOLAMCivica, Inc.f0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b2024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075243
application number: ANDA075243
MidazolamMIDAZOLAMHikma Pharmaceuticals USA Inc.f8bb3427-c887-47b6-8042-8a21dc161c792024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075243
application number: ANDA075243
MidazolamMIDAZOLAMHikma Pharmaceuticals USA Inc.8675cdb1-c7f5-40cf-b1e0-0960b7ab117b2024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075243
application number: ANDA075243
MidazolamMIDAZOLAMHikma Pharmaceuticals USA Inc.575d8bf0-7af7-427c-a231-966e2a5e070d2024-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075243
application number: ANDA075243

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0683-1500900683011 VIAL in 1 CARTON (50090-0683-1) > 10 mL in 1 VIAL1 vial2015-10-090000-00-00NoNoCurrent