Midazolam Hydrochloride

Product NDC: 68083-108
11-digit product format: 680830108
Labeler code: 68083
Product ID: 68083-108_3b7a93cb-a43a-46d0-ad52-6fba91da232d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midazolam Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA090850
Marketing category: ANDA
Marketing start: 2012-06-01
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 · 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…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
81b2f48d-a05c-4301-8fee-761af220d44f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1d526338-43ba-4cef-8730-5a757122f8ce	Product name	1	20260218
8118475d-d61b-4326-b353-56e9cf8c8d9f	Product name	3	20260218
f69f3735-bf62-03e6-cc7a-5af4af89ec8a	Product name	5	20250516
4cc03496-da49-494d-b71d-757fe6737fa2	Product name	1	20230717
06641162-4d53-492d-8ff2-5951a469060f	Product name	1	20230420
46ca420c-e4d5-4e6c-9b2f-cea269a262e8	Product name	1	20230320
b84efe2b-3f4e-4b09-90f9-1d24a61ec30e	Product name	1	20190808
bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16	Product name	1	20181220
31f18c4e-1938-700a-43de-b9e218c36edc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68083-108-01	Midazolam Hydrochloride	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	13
68083-108-01	Midazolam Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10	13
68083-108-02	Midazolam Hydrochloride	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	13
68083-108-02	Midazolam Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-108	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED]	13	Current NDC, Legacy NDC, 4 package rows	20231017_81b2f48d-a05c-4301-8fee-761af220d44f.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 ndc (product): 68083-108
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311702	midazolam 5 MG/ML Injectable Solution	PSN	81b2f48d-a05c-4301-8fee-761af220d44f	13
311702	midazolam 5 MG/ML Injectable Solution	SCD	81b2f48d-a05c-4301-8fee-761af220d44f	13
311702	midazolam (as midazolam hydrochloride) 5 MG/ML Injectable Solution	SY	81b2f48d-a05c-4301-8fee-761af220d44f	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-108-01	68083010801	10 VIAL, MULTI-DOSE in 1 CARTON (68083-108-01) / 5 mL in 1 VIAL, MULTI-DOSE	2012-06-01	0000-00-00	No	No	Current
68083-108-02	68083010802	10 VIAL, MULTI-DOSE in 1 CARTON (68083-108-02) / 10 mL in 1 VIAL, MULTI-DOSE	2012-06-01	0000-00-00	No	No	Current