midazolam in sodium chloride (65219-650)

Drug Facts

Product Profile

Brand Name midazolam in sodium chloride

Generic Name midazolam in sodium chloride

Labeler fresenius kabi usa, llc

Dosage Form INJECTION, SOLUTION

Routes

INTRAVENOUS

Active Ingredients

midazolam hydrochloride 1 mg/mL

Manufacturer

FRESENIUS KABI USA, LLC

Identifiers & Regulatory

Product NDC 65219-650

Product ID 65219-650_a43f63a4-8a7f-4a1b-b9a0-4198486cfef6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA218993

DEA Schedule civ

Listing Expiration 2026-12-31

Marketing Start 2025-01-15

Pharmacologic Class

Classes

benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219650

Hyphenated Format 65219-650

Supplemental Identifiers

RxCUI

2541170 2541171

UPC

0365219650027 0365219650058

UNII

W7TTW573JJ

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 sodium chloride (source: ndc)

Generic Name midazolam in sodium chloride (source: ndc)

Application Number ANDA218993 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

1 mg/mL

source: ndc

Packaging

10 POUCH in 1 CARTON (65219-650-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
10 POUCH in 1 CARTON (65219-650-50) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

source: ndc

Packages (2)

65219-650-10 10 POUCH in 1 CARTON (65219-650-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG 65219-650-50 10 POUCH in 1 CARTON (65219-650-50) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

Ingredients (1)

midazolam hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Midazolam In Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "a43f63a4-8a7f-4a1b-b9a0-4198486cfef6", "openfda": {"upc": ["0365219650027", "0365219650058"], "unii": ["W7TTW573JJ"], "rxcui": ["2541170", "2541171"], "spl_set_id": ["c8f51630-e776-4bc6-ba4d-b714e8c3b8f2"], "manufacturer_name": ["FRESENIUS KABI USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (65219-650-10)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "65219-650-10", "marketing_start_date": "20250115"}, {"sample": false, "description": "10 POUCH in 1 CARTON (65219-650-50)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG", "package_ndc": "65219-650-50", "marketing_start_date": "20250115"}], "brand_name": "Midazolam In Sodium Chloride", "product_id": "65219-650_a43f63a4-8a7f-4a1b-b9a0-4198486cfef6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "65219-650", "dea_schedule": "CIV", "generic_name": "Midazolam In Sodium Chloride", "labeler_name": "FRESENIUS KABI USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam In Sodium Chloride", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA218993", "marketing_category": "ANDA", "marketing_start_date": "20250115", "listing_expiration_date": "20261231"}