midazolam in 0.8% sodium chloride

Generic: midazolam in 0.8% sodium chloride

Labeler: b. braun medical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam in 0.8% sodium chloride
Generic Name midazolam in 0.8% sodium chloride
Labeler b. braun medical inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

midazolam 1 mg/mL

Manufacturer
B. Braun Medical Inc.

Identifiers & Regulatory

Product NDC 0264-8002
Product ID 0264-8002_1287da80-6b0a-4ba3-b698-d1dc0e78c294
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218454
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-10-15

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02648002
Hyphenated Format 0264-8002

Supplemental Identifiers

RxCUI
2541170 2541171
UNII
R60L0SM5BC
NUI
N0000175694 M0002356

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name midazolam in 0.8% sodium chloride (source: ndc)
Generic Name midazolam in 0.8% sodium chloride (source: ndc)
Application Number ANDA218454 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 30 CONTAINER in 1 CASE (0264-8002-32) / 100 mL in 1 CONTAINER
source: ndc

Packages (1)

0264-8002-32 30 CONTAINER in 1 CASE (0264-8002-32) / 100 mL in 1 CONTAINER

Ingredients (1)

midazolam (1 mg/mL)

Linked Drug Pages (1)

MIDAZOLAM IN 0.8% SODIUM CHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1287da80-6b0a-4ba3-b698-d1dc0e78c294", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["R60L0SM5BC"], "rxcui": ["2541170", "2541171"], "spl_set_id": ["adfe8ece-496d-4118-9990-a1d44d0ac7d9"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["B. Braun Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CONTAINER in 1 CASE (0264-8002-32)  / 100 mL in 1 CONTAINER", "package_ndc": "0264-8002-32", "marketing_start_date": "20251015"}], "brand_name": "MIDAZOLAM IN 0.8% SODIUM CHLORIDE", "product_id": "0264-8002_1287da80-6b0a-4ba3-b698-d1dc0e78c294", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0264-8002", "dea_schedule": "CIV", "generic_name": "MIDAZOLAM IN 0.8% SODIUM CHLORIDE", "labeler_name": "B. Braun Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MIDAZOLAM IN 0.8% SODIUM CHLORIDE", "active_ingredients": [{"name": "MIDAZOLAM", "strength": "1 mg/mL"}], "application_number": "ANDA218454", "marketing_category": "ANDA", "marketing_start_date": "20251015", "listing_expiration_date": "20261231"}