Home NDC 44567-611 Midazolam in Sodium Chloride
Product NDC 44567-611
11-digit product format 445670611
Labeler code 44567
Product ID 44567-611_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 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 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.
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 2026-08-01 22:54:32 2026-06 N211844-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N211844-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-03-22 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N211844-001 AP 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N211844-002 AP 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N211844-001 10966990 2038-06-20 Drug product 2021-04-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N211844-002 10966990 2038-06-20 Drug product 2021-04-16 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 44567-611-01 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 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
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 44567-611-01 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