midazolam

Generic: midazolam

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam
Generic Name midazolam
Labeler henry schein, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

midazolam hydrochloride 5 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9801
Product ID 0404-9801_425d6ca2-4545-4cf1-9c27-221d4f3e98c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075243
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-12-03

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049801
Hyphenated Format 0404-9801

Supplemental Identifiers

RxCUI
311702
UNII
W7TTW573JJ

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 (source: ndc)
Generic Name midazolam (source: ndc)
Application Number ANDA075243 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BAG (0404-9801-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

0404-9801-10 1 VIAL in 1 BAG (0404-9801-10) / 10 mL in 1 VIAL

Ingredients (1)

midazolam hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Midazolam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "425d6ca2-4545-4cf1-9c27-221d4f3e98c2", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["311702"], "spl_set_id": ["78e28b13-414e-4c34-a42c-caf1c3ba1f54"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BAG (0404-9801-10)  / 10 mL in 1 VIAL", "package_ndc": "0404-9801-10", "marketing_start_date": "20241203"}], "brand_name": "Midazolam", "product_id": "0404-9801_425d6ca2-4545-4cf1-9c27-221d4f3e98c2", "dosage_form": "INJECTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0404-9801", "dea_schedule": "CIV", "generic_name": "Midazolam", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA075243", "marketing_category": "ANDA", "marketing_start_date": "20241203", "listing_expiration_date": "20261231"}