Midazolam

Product NDC: 0641-6190
11-digit product format: 006416190
Labeler code: 0641
Product ID: 0641-6190_9ed8a0bb-bfd0-4f63-aa40-9813dd4a8f4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midazolam
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA075243
Marketing category: ANDA
Marketing start: 2000-06-20
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075243-001	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2000-06-20
A075243-002	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2000-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075243-001	AP
A075243-002	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 · 84 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	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075243-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075243-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075243-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075243-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075243-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075243-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075243-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075243-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075243-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075243-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075243-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075243-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075243-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075243-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075243-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075243-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075243-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075243-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075243-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075243-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075243-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075243-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075243-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075243-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075243-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075243-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075243-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075243-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075243-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075243-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075243-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075243-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075243-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075243-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075243-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075243-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075243-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075243-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075243-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075243-002	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Midazolam
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311702	Internal RxNorm lookup
1666798	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
f8bb3427-c887-47b6-8042-8a21dc161c79	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	Strength	SPL version
0641-6190-01	Midazolam	10 mL in 1 VIAL	INJECTION	10		8
0641-6190-10	Midazolam	10 in 1 CARTON	INJECTION	10		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6190-01	ML - Milliliter	0641-6190	584262a2-67e4-4f8c-ae73-73517c84edcc	1	2017-03-06
0641-6190-10	ML - Milliliter	0641-6190	c556ac86-85c1-47ee-b11a-f8658a537bce	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6190	MIDAZOLAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]	8	Current NDC, Legacy NDC, 2 package rows	20241219_f8bb3427-c887-47b6-8042-8a21dc161c79.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam	MIDAZOLAM	Henry Schein, Inc.	3c2fd6ee-4ede-4ee4-8c05-34c93598f381	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243
Midazolam	MIDAZOLAM	Henry Schein, Inc.	78e28b13-414e-4c34-a42c-caf1c3ba1f54	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243
Midazolam	MIDAZOLAM	Henry Schein, Inc.	94e1342b-f597-44c0-b8fc-b753fde04cbe	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243
Midazolam	MIDAZOLAM	Civica, Inc.	f0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243
Midazolam	MIDAZOLAM	Hikma Pharmaceuticals USA Inc.	f8bb3427-c887-47b6-8042-8a21dc161c79	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243 ndc (product): 0641-6190
Midazolam	MIDAZOLAM	Hikma Pharmaceuticals USA Inc.	8675cdb1-c7f5-40cf-b1e0-0960b7ab117b	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243
Midazolam	MIDAZOLAM	Hikma Pharmaceuticals USA Inc.	575d8bf0-7af7-427c-a231-966e2a5e070d	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1666798	midazolam 2 MG in 2 ML Injection	PSN	f8bb3427-c887-47b6-8042-8a21dc161c79	8
311702	midazolam 5 MG/ML Injectable Solution	PSN	f8bb3427-c887-47b6-8042-8a21dc161c79	8
1666798	2 ML midazolam 1 MG/ML Injection	SCD	f8bb3427-c887-47b6-8042-8a21dc161c79	8
311702	midazolam 5 MG/ML Injectable Solution	SCD	f8bb3427-c887-47b6-8042-8a21dc161c79	8
311702	midazolam (as midazolam hydrochloride) 5 MG/ML Injectable Solution	SY	f8bb3427-c887-47b6-8042-8a21dc161c79	8
1666798	midazolam 2 MG per 2 ML Injection	SY	f8bb3427-c887-47b6-8042-8a21dc161c79	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6190-01	00641619001	10 mL in 1 VIAL	10 ml					Historical
0641-6190-10	00641619010	10 VIAL in 1 CARTON (0641-6190-10) / 10 mL in 1 VIAL (0641-6190-01)	10 vial	2000-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midazolam Injection, USP - NOVAPLUS®	Hikma Pharmaceuticals USA Inc.	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	8