Home NDC 0264-8002 MIDAZOLAM IN 0.8% SODIUM CHLORIDE
Product NDC 0264-8002
11-digit product format 002648002
Labeler code 0264
Product ID 0264-8002_1287da80-6b0a-4ba3-b698-d1dc0e78c294
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MIDAZOLAM IN 0.8% SODIUM CHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application ANDA218454
Marketing category ANDA
Marketing start 2025-10-15
Substance MIDAZOLAM
Active strength 1 mg/mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
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 A218454-001 MIDAZOLAM IN 0.8% SODIUM CHLORIDE MIDAZOLAM 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01 A218454-002 MIDAZOLAM IN 0.8% SODIUM CHLORIDE MIDAZOLAM 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01
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 2026-08-18 06:07:40 2026-07 A218454-001 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218454-002 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218454-001 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218454-002 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218454-001 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218454-002 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218454-001 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218454-002 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218454-001 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218454-002 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RS 2025-05-01 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base MIDAZOLAM IN 0.8% SODIUM CHLORIDE
Listing expiration 2026-12-31 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 0264-8002-32 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 100 mL in 1 CONTAINER INJECTION, SOLUTION 100 3 0264-8002-32 MIDAZOLAM IN 0.8% SODIUM CHLORIDE 30 in 1 CASE INJECTION, SOLUTION 30 3
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 Sample Exclude flag Status 0264-8002-32 00264800232 30 CONTAINER in 1 CASE (0264-8002-32) / 100 mL in 1 CONTAINER 30 container 2025-10-15 No No Current