Midazolam in Sodium Chloride

Product NDC: 44567-611
11-digit product format: 445670611
Labeler code: 44567
Product ID: 44567-611_eedc698f-65b8-4d19-9194-234f05634f71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midazolam
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: WG Critical Care, LLC.
Application: NDA211844
Marketing category: NDA
Marketing start: 2020-12-31
Substance: MIDAZOLAM
Active strength: 1 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
N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22
N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N211844-001	AP
N211844-002	AP

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211844-001	10966990	2038-06-20		Drug product	2021-04-16
N211844-002	10966990	2038-06-20		Drug product	2021-04-16

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 · 72 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	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-03-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-03-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-03-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-03-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-03-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-03-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 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	N211844-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211844-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211844-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211844-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211844-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211844-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211844-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211844-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211844-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211844-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211844-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211844-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211844-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211844-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211844-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211844-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211844-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211844-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211844-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211844-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211844-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211844-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211844-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211844-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211844-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211844-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211844-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211844-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211844-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211844-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211844-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211844-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211844-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211844-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211844-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211844-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211844-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211844-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211844-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211844-002	AP	1	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211844-001	10966990	2038-06-20	Drug product	2021-04-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211844-002	10966990	2038-06-20	Drug product	2021-04-16	`bb7c543d1eb4…`

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 in Sodium Chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIDAZOLAM	1 mg/mL

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
44567-611-01	Midazolam in Sodium Chloride	100 mL in 1 BAG	INJECTION, SOLUTION	100		15
44567-611-10	Midazolam in Sodium Chloride	10 in 1 CARTON	INJECTION, SOLUTION	10		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44567-611-01	ML - Milliliter	44567-611	ab8191f0-8dfd-4457-9054-8ea3158dcd98	1	2021-09-07
44567-611-10	ML - Milliliter	44567-611	3dc0bf79-9534-487c-9299-6f36117a08d9	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44567-611	MIDAZOLAM IN SODIUM CHLORIDE (MIDAZOLAM) INJECTION, SOLUTION [WG CRITICAL CARE, LLC.]	12	Current NDC, Legacy NDC, 2 package rows	20250108_f051776f-94c5-4e34-80ed-f45b9c36881e.zip

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
2541171	midazolam 100 MG in 100 mL Injection	PSN	f051776f-94c5-4e34-80ed-f45b9c36881e	15
2541170	midazolam 50 MG in 50 mL Injection	PSN	f051776f-94c5-4e34-80ed-f45b9c36881e	15
2541171	100 ML midazolam 1 MG/ML Injection	SCD	f051776f-94c5-4e34-80ed-f45b9c36881e	15
2541170	50 ML midazolam 1 MG/ML Injection	SCD	f051776f-94c5-4e34-80ed-f45b9c36881e	15
2541171	midazolam 100 MG per 100 ML Injection	SY	f051776f-94c5-4e34-80ed-f45b9c36881e	15
2541170	midazolam 50 MG per 50 ML Injection	SY	f051776f-94c5-4e34-80ed-f45b9c36881e	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44567-611-01	44567061101	100 mL in 1 BAG	100 ml					Historical
44567-611-10	44567061110	10 BAG in 1 CARTON (44567-611-10) / 100 mL in 1 BAG (44567-611-01)	10 bag	2021-04-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midazolam in Sodium Chloride	WG Critical Care, LLC. \| InfoRLife SA	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	15