midazolam

Product NDC: 72611-749
11-digit product format: 726110749
Labeler code: 72611
Product ID: 72611-749_8c7492f1-de34-ab19-2abe-d7e67799b03f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: midazolam
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Almaject, Inc.
Application: ANDA090850
Marketing category: ANDA
Marketing start: 2020-04-14
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72611-749		D	Discontinued by firm		2026-08-17
excluded package	package	72611-749	72611-749-10	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090850-001	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2012-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090850-001	AP

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090850-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2012-01-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090850-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090850-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090850-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090850-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090850-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090850-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090850-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090850-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090850-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090850-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090850-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090850-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090850-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090850-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090850-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090850-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090850-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090850-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090850-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090850-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090850-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090850-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090850-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090850-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090850-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090850-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090850-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090850-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090850-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090850-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090850-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090850-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090850-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090850-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090850-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090850-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090850-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090850-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090850-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090850-001	AP	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72611-749-01	ML - Milliliter	72611-749	818a0334-e1bc-4c76-8e20-be4bd39fc9ac	1	2020-09-14
72611-749-10	ML - Milliliter	72611-749	5212349c-33e4-4f97-ae24-464f382592b5	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72611-749	MIDAZOLAM INJECTION, SOLUTION [ALMAJECT, INC.]	5	Legacy NDC	20241101_9532689f-bf0f-5854-98ef-543a0ae2d8c8.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Jvet Pharmaceuticals LLC	a84ddd02-1f5f-4311-9dae-2a5cb4064bf3	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090850 application number: ANDA090850
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Belcher Pharmaceuticals, LLC	cee4cdd0-58c5-4704-9fb6-d4bffb1764a8	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090850 application number: ANDA090850
midazolam	MIDAZOLAM HYDROCHLORIDE	Sagent Pharmaceuticals	880cac48-5c0f-49a9-8aef-3c9770bf5d84	2023-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090850 application number: ANDA090850
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Gland Pharma Limited	81b2f48d-a05c-4301-8fee-761af220d44f	2023-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090850 application number: ANDA090850
Midazolam hydrochloride	MIDAZOLAM HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	843cc25e-45ea-4372-ae34-843f805fa869	2023-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090850 application number: ANDA090850

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W7TTW573JJ	MIDAZOLAM HYDROCHLORIDE	59467-96-8	MIDAZOLAM HYDROCHLORIDE
R60L0SM5BC	MIDAZOLAM	59467-70-8	midazolam

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72611-749-10	72611074910	10 VIAL, MULTI-DOSE in 1 CARTON (72611-749-10) > 10 mL in 1 VIAL, MULTI-DOSE (72611-749-01)	2020-04-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midazolam Injection, USP CIV (For Intravenous or Intramuscular Use Only)	Almaject, Inc.	2024-10-29	HUMAN PRESCRIPTION DRUG LABEL	5
MIDAZOLAM	Henry Schein, Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	5
MIDAZOLAM	General Injectables and Vaccines, Inc.	2022-12-28	HUMAN PRESCRIPTION DRUG LABEL	3