Midazolam

Product NDC: 76045-211
11-digit product format: 760450211
Labeler code: 76045
Product ID: 76045-211_ec9c9aee-b95f-4645-bf17-df7f1e3967d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midazolam Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA203460
Marketing category: ANDA
Marketing start: 2021-04-16
Substance: MIDAZOLAM HYDROCHLORIDE
Active strength: 2 mg/2mL
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
A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2014-08-22
A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2014-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203460-001	AP
A203460-002	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	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`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	A203460-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203460-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203460-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203460-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203460-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203460-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203460-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203460-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203460-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203460-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203460-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203460-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203460-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203460-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203460-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203460-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203460-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203460-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203460-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203460-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203460-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203460-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203460-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203460-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203460-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203460-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203460-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203460-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203460-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203460-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203460-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203460-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203460-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203460-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203460-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203460-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203460-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203460-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203460-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203460-002	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	2 mg/2mL

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998211	Internal RxNorm lookup
1551393	Internal RxNorm lookup
1551395	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
1cc9ba6e-fa1b-405e-9de8-720c567b2a73	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
b84efe2b-3f4e-4b09-90f9-1d24a61ec30e	Product name	1	20190808
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16	Product name	1	20181220
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
31f18c4e-1938-700a-43de-b9e218c36edc	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76045-211-00	Midazolam	1 in 1 BLISTER PACK	INJECTION, SOLUTION	1	16
76045-211-00	Midazolam	2 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	2	16
76045-211-20	Midazolam	24 in 1 CARTON	INJECTION, SOLUTION	24	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76045-211-00	ML - Milliliter	76045-211	92d515ec-203d-4d46-b1dd-068b45c888bb	1	2025-05-14
76045-211-20	ML - Milliliter	76045-211	bbc28f32-0448-4635-a3b3-a8ed1f08cfb3	1	2025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Midazolam Hydrochloride	ACTIVE INGREDIENT	W7TTW573JJ	MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]	1
Midazolam	ACTIVE MOIETY	R60L0SM5BC	MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]	1
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]	1
Sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [BD RX INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76045-211	MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	16	Current NDC, Legacy NDC, 3 package rows	20240119_1cc9ba6e-fa1b-405e-9de8-720c567b2a73.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam	MIDAZOLAM HYDROCHLORIDE	Fresenius Kabi USA, LLC	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203460 application number: ANDA203460 ndc (product): 76045-211

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
1551393	midazolam 10 MG in 2 ML Prefilled Syringe	PSN	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	16
998211	midazolam 2 MG in 2 ML Prefilled Syringe	PSN	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	16
1551395	midazolam 5 MG in 1 ML Prefilled Syringe	PSN	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	16
1551395	1 ML midazolam 5 MG/ML Prefilled Syringe	SCD	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	16
998211	2 ML midazolam 1 MG/ML Prefilled Syringe	SCD	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	16
1551393	2 ML midazolam 5 MG/ML Prefilled Syringe	SCD	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	16
1551393	midazolam (as midazolam hydrochloride) 10 MG per 2 ML Prefilled Syringe	SY	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	16
998211	midazolam (as midazolam hydrochloride) 2 MG per 2 ML Prefilled Syringe	SY	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	16
1551395	midazolam (as midazolam hydrochloride) 5 MG per 1 ML Prefilled Syringe	SY	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76045-211-00	76045021100	1 in 1 BLISTER PACK						Historical
76045-211-20	76045021120	24 BLISTER PACK in 1 CARTON (76045-211-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-211-00) / 2 mL in 1 SYRINGE, GLASS	24 blister pack	2021-04-16	0000-00-00	No	No	Current