midazolam

Generic: midazolam hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam
Generic Name midazolam hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

midazolam hydrochloride 2 mg/2mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 76045-211
Product ID 76045-211_ec9c9aee-b95f-4645-bf17-df7f1e3967d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203460
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-04-16

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76045211
Hyphenated Format 76045-211

Supplemental Identifiers

RxCUI
998211 1551393 1551395
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 ANDA203460 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/2mL
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (76045-211-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-211-00) / 2 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

76045-211-20 24 BLISTER PACK in 1 CARTON (76045-211-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-211-00) / 2 mL in 1 SYRINGE, GLASS

Ingredients (1)

midazolam hydrochloride (2 mg/2mL)

Linked Drug Pages (1)

Midazolam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "ec9c9aee-b95f-4645-bf17-df7f1e3967d3", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["998211", "1551393", "1551395"], "spl_set_id": ["1cc9ba6e-fa1b-405e-9de8-720c567b2a73"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (76045-211-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-211-00)  / 2 mL in 1 SYRINGE, GLASS", "package_ndc": "76045-211-20", "marketing_start_date": "20210416"}], "brand_name": "Midazolam", "product_id": "76045-211_ec9c9aee-b95f-4645-bf17-df7f1e3967d3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "76045-211", "dea_schedule": "CIV", "generic_name": "Midazolam Hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "2 mg/2mL"}], "application_number": "ANDA203460", "marketing_category": "ANDA", "marketing_start_date": "20210416", "listing_expiration_date": "20261231"}