Midazolam

Product NDC: 0409-2596
Requested package NDC: 0409-2596-05
11-digit product format: 004092596
Labeler code: 0409
Product ID: 0409-2596_6c075a2d-b68b-41a7-aa0c-bcf9894e3f76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MIDAZOLAM HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA075293
Marketing category: ANDA
Marketing start: 2005-11-03
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
A075293-001	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20
A075293-002	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	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
A075293-001	AP
A075293-002	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A075293-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075293-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075293-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075293-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075293-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075293-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075293-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075293-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075293-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075293-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075293-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075293-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075293-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075293-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075293-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075293-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075293-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075293-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075293-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075293-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075293-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075293-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075293-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075293-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075293-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075293-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075293-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075293-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075293-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075293-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075293-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075293-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075293-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075293-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075293-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075293-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075293-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075293-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075293-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075293-002	AP	1	`74a2ff9319b5…`

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
affecd4d-1f78-4bbe-5a8d-86849bbdc520	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-2596-03	Midazolam	10 in 1 CARTON	INJECTION, SOLUTION	10	31
0409-2596-05	Midazolam	10 in 1 CARTON	INJECTION, SOLUTION	10	31
0409-2596-13	Midazolam	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	31
0409-2596-15	Midazolam	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-2596-03	ML - Milliliter	0409-2596	665b2b30-f374-49e8-98db-39812f85c708	1	2012-07-24
0409-2596-05	ML - Milliliter	0409-2596	7267b9f0-b727-45bb-a1ad-d762f8f31d47	1	2012-07-24
0409-2596-13	ML - Milliliter	0409-2596	747a5c15-0a17-4ec3-b190-7371030b92ae	1	2020-02-13
0409-2596-15	ML - Milliliter	0409-2596	3fcca094-4902-444f-9cbc-d6c066fa7d2b	1	2020-02-13
0409-2596-52	ML - Milliliter	0409-2596	58bbe8c4-7390-41b7-8e38-e5240567f40d	1	2012-07-24
0409-2596-53	ML - Milliliter	0409-2596	afed244b-6725-4e9f-a762-cba1dc1db08a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIDAZOLAM HYDROCHLORIDE	ACTIVE INGREDIENT	W7TTW573JJ	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
MIDAZOLAM	ACTIVE MOIETY	R60L0SM5BC	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	12
MIDAZOLAM HYDROCHLORIDE	ACTIVE INGREDIENT	W7TTW573JJ	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	2
MIDAZOLAM	ACTIVE MOIETY	R60L0SM5BC	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-2596	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]	28	Current NDC, Legacy NDC, 4 package rows	20241220_affecd4d-1f78-4bbe-5a8d-86849bbdc520.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	A-S Medication Solutions	5e85e477-d483-4345-8d7b-d7dcdc3e0652	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075293 application number: ANDA075293
Midazolam	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	affecd4d-1f78-4bbe-5a8d-86849bbdc520	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075293 application number: ANDA075293 ndc (package): 0409-2596-05 ndc (product): 0409-2596 ndc11 (package): 00409259605
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	A-S Medication Solutions	b7effb82-e180-46f0-b2e8-a0d8ebc32a2a	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075293 application number: ANDA075293
Midazolam	MIDAZOLAM	Henry Schein, Inc.	90f7b7f6-d0fd-40af-bbfa-70b152e3e27c	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075293 application number: ANDA075293

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
311700	midazolam 1 MG/ML Injectable Solution	PSN	affecd4d-1f78-4bbe-5a8d-86849bbdc520	31
311702	midazolam 5 MG/ML Injectable Solution	PSN	affecd4d-1f78-4bbe-5a8d-86849bbdc520	31
311700	midazolam 1 MG/ML Injectable Solution	SCD	affecd4d-1f78-4bbe-5a8d-86849bbdc520	31
311702	midazolam 5 MG/ML Injectable Solution	SCD	affecd4d-1f78-4bbe-5a8d-86849bbdc520	31
311700	midazolam (as midazolam hydrochloride) 1 MG/ML Injectable Solution	SY	affecd4d-1f78-4bbe-5a8d-86849bbdc520	31
311702	midazolam (as midazolam hydrochloride) 5 MG/ML Injectable Solution	SY	affecd4d-1f78-4bbe-5a8d-86849bbdc520	31
311702	midazolam 5 MG/ML Injectable Solution	PSN	5e85e477-d483-4345-8d7b-d7dcdc3e0652	10
311702	midazolam 5 MG/ML Injectable Solution	SCD	5e85e477-d483-4345-8d7b-d7dcdc3e0652	10
311702	midazolam (as midazolam hydrochloride) 5 MG/ML Injectable Solution	SY	5e85e477-d483-4345-8d7b-d7dcdc3e0652	10
311702	midazolam 5 MG/ML Injectable Solution	PSN	90f7b7f6-d0fd-40af-bbfa-70b152e3e27c	6
311702	midazolam 5 MG/ML Injectable Solution	SCD	90f7b7f6-d0fd-40af-bbfa-70b152e3e27c	6
311702	midazolam (as midazolam hydrochloride) 5 MG/ML Injectable Solution	SY	90f7b7f6-d0fd-40af-bbfa-70b152e3e27c	6
311702	midazolam 5 MG/ML Injectable Solution	PSN	249af7c9-8e3a-4fae-aa78-46bbeab44fe1	2
311702	midazolam 5 MG/ML Injectable Solution	SCD	249af7c9-8e3a-4fae-aa78-46bbeab44fe1	2
311702	midazolam (as midazolam hydrochloride) 5 MG/ML Injectable Solution	SY	249af7c9-8e3a-4fae-aa78-46bbeab44fe1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-2596-05	00409259605	10 VIAL, MULTI-DOSE in 1 CARTON (0409-2596-05) / 10 mL in 1 VIAL, MULTI-DOSE (0409-2596-15)	2006-01-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midazolam Injection, USP	A-S Medication Solutions	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	12
Midazolam Injection, USP	Hospira, Inc.	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	31
Midazolam	Henry Schein, Inc.	2025-10-31	HUMAN PRESCRIPTION DRUG LABEL	6
Midazolam	General Injectables and Vaccines, Inc.	2021-11-17	HUMAN PRESCRIPTION DRUG LABEL	4
Midazolam Injection, USP	Hospira, Inc.	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	14
Midazolam Injection, USP	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-02-15	HUMAN PRESCRIPTION DRUG LABEL	2