midazolam hydrochloride

Generic: midazolam hydrochloride

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam hydrochloride
Generic Name midazolam hydrochloride
Labeler padagis us llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

midazolam hydrochloride 2 mg/mL

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-0150
Product ID 0574-0150_d7b8dd9f-1acd-4d10-afbf-a57a93154a6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076379
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2005-05-02

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05740150
Hyphenated Format 0574-0150

Supplemental Identifiers

RxCUI
422410
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 hydrochloride (source: ndc)
Generic Name midazolam hydrochloride (source: ndc)
Application Number ANDA076379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (0574-0150-04) / 118 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

0574-0150-04 1 BOTTLE, GLASS in 1 CARTON (0574-0150-04) / 118 mL in 1 BOTTLE, GLASS

Ingredients (1)

midazolam hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Midazolam Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d7b8dd9f-1acd-4d10-afbf-a57a93154a6b", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["422410"], "spl_set_id": ["0be63f63-6a93-4782-8f9c-d13ca5ae44bd"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (0574-0150-04)  / 118 mL in 1 BOTTLE, GLASS", "package_ndc": "0574-0150-04", "marketing_start_date": "20050502"}], "brand_name": "Midazolam Hydrochloride", "product_id": "0574-0150_d7b8dd9f-1acd-4d10-afbf-a57a93154a6b", "dosage_form": "SYRUP", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0574-0150", "dea_schedule": "CIV", "generic_name": "Midazolam Hydrochloride", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam Hydrochloride", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA076379", "marketing_category": "ANDA", "marketing_start_date": "20050502", "listing_expiration_date": "20261231"}