Midazolam

Product NDC: 83270-176
11-digit product format: 832700176
Labeler code: 83270
Product ID: 83270-176_58da75f1-55f4-4722-e063-6394a90aed9a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: midazolam hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Onesource Specialty Pharma Limited
Application: ANDA090316
Marketing category: ANDA
Marketing start: 2026-02-27
Substance: MIDAZOLAM HYDROCHLORIDE
Active strength: 5 mg/mL
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090316-001	MIDOZALAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2011-05-04
A090316-002	MIDOZALAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2011-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090316-001	AP
A090316-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`74a2ff9319b5…`

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
2026-09-14 22:38:34	2026-08	A090316-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090316-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090316-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090316-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090316-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090316-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090316-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090316-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090316-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090316-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090316-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090316-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090316-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090316-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090316-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090316-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090316-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090316-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090316-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090316-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090316-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090316-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090316-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090316-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090316-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090316-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090316-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090316-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090316-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090316-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090316-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090316-002	AP	1	`8072bd15b7f6…`
2019-09-15 20:21 UTC	2019-09	A090316-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090316-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090316-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090316-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090316-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090316-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090316-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090316-002	AP	1	`1c564ffb4f44…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Midazolam
Listing expiration: 2027-12-31

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
311700	Internal RxNorm lookup
311702	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a0e9a149-7a4c-4f66-91af-91695ee2e40c	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam	MIDAZOLAM HYDROCHLORIDE	Onesource Specialty Pharma Limited	a0e9a149-7a4c-4f66-91af-91695ee2e40c	2026-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090316 application number: ANDA090316 ndc (product): 83270-176
Midazolam	MIDAZOLAM HYDROCHLORIDE	Steriscience Specialties Private Limited	473fba4b-8754-4b1d-bba9-d9c8f6d818e0	2023-12-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090316 application number: ANDA090316
Midazolam	MIDAZOLAM HYDROCHLORIDE	SOMERSET THERAPEUTICS, LLC	06e4f754-72df-4eb4-aaed-b538524f5277	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090316 application number: ANDA090316

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83270-176-10	83270017610	10 VIAL in 1 CARTON (83270-176-10) / 10 mL in 1 VIAL	10 vial	2026-02-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midazolam Injection, USP For intravenous or intramuscular use	Onesource Specialty Pharma Limited \| Onesource Specialty Pte. Limited	2026-08-12	HUMAN PRESCRIPTION DRUG LABEL	1