Home NDC 44567-610 Midazolam in Sodium Chloride
Product NDC 44567-610
11-digit product format 445670610
Labeler code 44567
Product ID 44567-610_6cea9d5b-d0a6-4f93-b45e-2d615f6c4337
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 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 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.
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 · 70 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 2026-08-18 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…2021-12-28 21:50 UTC 2021-12 N211844-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-03-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N211844-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-03-22 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 68 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2021-12-28 21:50 UTC 2021-12 N211844-001 10966990 2038-06-20 Drug product 2021-04-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N211844-002 10966990 2038-06-20 Drug product 2021-04-16 782e0a99824c…
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
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2541170 Internal RxNorm lookup 2541171 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44567-610-01 Midazolam in Sodium Chloride 50 mL in 1 BAG INJECTION, SOLUTION 50 15 44567-610-10 Midazolam in Sodium Chloride 10 in 1 CARTON INJECTION, SOLUTION 10 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-610 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
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44567-610-01 44567061001 50 mL in 1 BAG 50 ml Historical 44567-610-10 44567061010 10 BAG in 1 CARTON (44567-610-10) / 50 mL in 1 BAG (44567-610-01) 10 bag 2021-04-19 0000-00-00 No No Current