midazolam

Generic: midazolam hydrochloride

Labeler: steriscience specialties private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam
Generic Name midazolam hydrochloride
Labeler steriscience specialties private limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

midazolam hydrochloride 5 mg/mL

Manufacturer
Steriscience Specialties Private Limited

Identifiers & Regulatory

Product NDC 82449-209
Product ID 82449-209_0c638f3c-bdd6-8385-e063-6394a90a53ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090316
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-07-31

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82449209
Hyphenated Format 82449-209

Supplemental Identifiers

RxCUI
311700 311702
UPC
0382449207012
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 (source: ndc)
Generic Name midazolam hydrochloride (source: ndc)
Application Number ANDA090316 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (82449-209-02) / 10 mL in 1 VIAL
source: ndc

Packages (1)

82449-209-02 10 VIAL in 1 CARTON (82449-209-02) / 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": "0c638f3c-bdd6-8385-e063-6394a90a53ef", "openfda": {"upc": ["0382449207012"], "unii": ["W7TTW573JJ"], "rxcui": ["311700", "311702"], "spl_set_id": ["473fba4b-8754-4b1d-bba9-d9c8f6d818e0"], "manufacturer_name": ["Steriscience Specialties Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (82449-209-02)  / 10 mL in 1 VIAL", "package_ndc": "82449-209-02", "marketing_start_date": "20230731"}], "brand_name": "Midazolam", "product_id": "82449-209_0c638f3c-bdd6-8385-e063-6394a90a53ef", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "82449-209", "dea_schedule": "CIV", "generic_name": "midazolam hydrochloride", "labeler_name": "Steriscience Specialties Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA090316", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}