midazolam hydrochloride

Generic: midazolam hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam hydrochloride
Generic Name midazolam hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

midazolam hydrochloride 2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3566
Product ID 0054-3566_fba22894-bfd7-4332-9d8b-34fc48389520
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075873
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2002-04-30

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00543566
Hyphenated Format 0054-3566

Supplemental Identifiers

RxCUI
422410
UPC
0300543566996
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 ANDA075873 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, GLASS (0054-3566-99)
source: ndc

Packages (1)

0054-3566-99 118 mL in 1 BOTTLE, GLASS (0054-3566-99)

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": "fba22894-bfd7-4332-9d8b-34fc48389520", "openfda": {"upc": ["0300543566996"], "unii": ["W7TTW573JJ"], "rxcui": ["422410"], "spl_set_id": ["a833c24b-6dca-44d7-a0d6-20012fa1ea77"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, GLASS (0054-3566-99)", "package_ndc": "0054-3566-99", "marketing_start_date": "20020430"}], "brand_name": "Midazolam Hydrochloride", "product_id": "0054-3566_fba22894-bfd7-4332-9d8b-34fc48389520", "dosage_form": "SYRUP", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0054-3566", "dea_schedule": "CIV", "generic_name": "Midazolam Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam Hydrochloride", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA075873", "marketing_category": "ANDA", "marketing_start_date": "20020430", "listing_expiration_date": "20261231"}