MIDAZOLAM HYDROCHLORIDE

Product NDC: 51754-2130
11-digit product format: 517542130
Labeler code: 51754
Product ID: 51754-2130_5aa322a4-0b10-4f41-ba56-508fc2b25229
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MIDAZOLAM HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Exela Pharma Sciences, LLC
Application: NDA215868
Marketing category: NDA
Marketing start: 2022-12-01
Marketing end: 0000-00-00
Substance: MIDAZOLAM HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51754-2130		D	Discontinued by firm		2026-08-03
excluded package	package	51754-2130	51754-2130-4	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51754-2130-4	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51754-2130-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51754-2130-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51754-2130-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51754-2130-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51754-2130-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51754-2130-4	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51754-2130-4	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51754-2130-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM	50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2022-07-20
N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2022-07-20

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 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`a67488948f0b…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51754-2130-4	2025-12-03	C162847	48780-1	2cef2736-8ec3-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use MIDAZOLAM IN 0.8% SODIUM CHLORIDE Injection safely and effectively. See full prescribing information for MIDAZOLAM IN 0.8% SODIUM CHLORIDE Injection. MIDAZOLAM IN 0.8% SODIUM CHLORIDE injection, for intravenous use, CIV Initial U.S. Approval: 1985
51754-2130-4	2025-01-30	C162847	48780-1	2cef2736-8ec3-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use MIDAZOLAM IN 0.8% SODIUM CHLORIDE Injection safely and effectively. See full prescribing information for MIDAZOLAM IN 0.8% SODIUM CHLORIDE Injection. MIDAZOLAM IN 0.8% SODIUM CHLORIDE injection, for intravenous use, CIV Initial U.S. Approval: 1985

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51754-2130	MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]	2	Legacy NDC	20221217_7b42059c-16ad-4826-829b-83b42a39435b.zip

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	Marketing end	Sample	Exclude flag	Status
51754-2130-4	51754213004	25 VIAL in 1 CARTON (51754-2130-4) > 50 mL in 1 VIAL	25 vial	2022-12-01	0000-00-00	No	No	Current