N/A

Product NDC: 71053-595
Requested package NDC: 71053-595-01
11-digit product format: 710530595
Labeler code: 71053
Product ID: 71053-595_4b1cba4c-3cc1-5642-e063-6294a90a4522
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midazolam Injection, 10 mg
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Rafa Laboratories, Ltd.
Application: NDA216359
Marketing category: NDA
Marketing start: 2022-08-08
Substance: MIDAZOLAM
Active strength: 10 mg/.7mL
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71053-595	71053-595-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	MIDAZOLAM HYDROCHLORIDE	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR		RLD, RS	2022-08-08

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIDAZOLAM	10 mg/.7mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R60L0SM5BC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2608698	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
d7362b4d-68a3-99a0-e053-2995a90a4f60	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-05-06	These highlights do not include all the information needed to use MIDAZOLAM INJECTION safely and effectively. See full prescribing information for MIDAZOLAM INJECTION. MIDAZOLAM injection, for intramuscular use, CIV Initial U.S. Approval: 1985
2024-01-30	These highlights do not include all the information needed to use MIDAZOLAM INJECTION safely and effectively. See full prescribing information for MIDAZOLAM INJECTION. MIDAZOLAM injection, for intramuscular use, CIV Initial U.S. Approval: 1985
2023-10-31	These highlights do not include all the information needed to use MIDAZOLAM INJECTION safely and effectively. See full prescribing information for MIDAZOLAM INJECTION. MIDAZOLAM injection, for intramuscular use, CIV Initial U.S. Approval: 1985
2023-07-28	These highlights do not include all the information needed to use MIDAZOLAM INJECTION safely and effectively. See full prescribing information for MIDAZOLAM INJECTION. MIDAZOLAM injection, for intramuscular use, CIV Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71053-595-01	N/A	40 in 1 CARTON	INJECTION, SOLUTION	40		5
71053-595-01	N/A	480 in 1 BOX	INJECTION, SOLUTION	480		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71053-595-01	ML - Milliliter	71053-595	a8907fff-be76-415b-bab6-7213c8130f2e	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71053-595	N/A (MIDAZOLAM INJECTION, 10 MG) INJECTION, SOLUTION [RAFA LABORATORIES, LTD.]	4	Current NDC, Legacy NDC, 2 package rows	20240510_d7362b4d-68a3-99a0-e053-2995a90a4f60.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
N/A	MIDAZOLAM INJECTION, 10 MG	Rafa Laboratories, Ltd.	d7362b4d-68a3-99a0-e053-2995a90a4f60	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216359 application number: NDA216359 ndc (package): 71053-595-01 ndc (product): 71053-595 ndc11 (package): 71053059501

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R60L0SM5BC	MIDAZOLAM	59467-70-8	MIDAZOLAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2608698	midazolam 10 MG in 0.7 ML Auto-Injector	PSN	d7362b4d-68a3-99a0-e053-2995a90a4f60	5
2608698	0.7 ML midazolam 14.3 MG/ML Auto-Injector	SCD	d7362b4d-68a3-99a0-e053-2995a90a4f60	5
2608698	midazolam 10 MG per 0.7 ML Auto-Injector	SY	d7362b4d-68a3-99a0-e053-2995a90a4f60	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71053-595-01	71053059501	480 CARTON in 1 BOX (71053-595-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE	480 carton	2022-08-08	0000-00-00	No	No	Current

N/A