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 10 mg/2mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 76045-003
Product ID 76045-003_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 2014-10-03

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76045003
Hyphenated Format 76045-003

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
  • 10 mg/2mL
source: ndc
Packaging
  • HOW SUPPLIED/STORAGE AND HANDLING Midazolam Injection, USP (Preservative-Free) is supplied as follows: Product Code Unit of Sale Strength Each RF766120 NDC 76045-211-20 Unit of 24 2 mg/2mL (1 mg/mL) NDC 76045-211-00 2 mL single-dose prefilled syringe This product contains an RFID. 766120 NDC 76045-001-20 Unit of 24 2 mg/2mL (1 mg/mL) NDC 76045-001-00 2 mL single-dose prefilled syringe 766210 NDC 76045-002-10 Unit of 24 5 mg/mL NDC 76045-002-00 1 mL single-dose prefilled syringe Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Do not place syringe on a sterile field. Animal Toxicology and/or Pharmacology Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester through the first several months of life, but may extend out to approximately 3 years of age in humans. In primates, exposure to 3 hours of an anesthetic regimen that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer increased neuronal cell loss. Data in rodents and in primates suggest that the neuronal and oligodendrocyte cell losses are associated with subtle but prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in neonates and young children who require procedures against the potential risks suggested by the nonclinical data. (see WARNINGS, Pediatric Neurotoxicity and PRECAUTIONS, Pregnancy and Pediatric Use )
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Midazolam 2 mL Carton Panel Rx only NDC 76045-211-20 Midazolam Injection, USP CIV Preservative Free 2 mg / 2 mL (1 mg / mL) For Intravenous or Intramuscular use only. Do NOT place syringe on a Sterile Field. 24 X 2 mL Single-dose prefilled syringes Discard unused portion. PACKAGE LABEL - PRINCIPAL DISPLAY - Midazolam 2 mL Carton Panel
  • PACKAGE LABEL – PRINCIPAL DISPLAY - Midazolam 2 mL Blister Pack Label RF766120 NDC 76045-211-00 Midazolam Injection, USP CIV 2 mg/2 mL (1 mg/mL) Preservative Free For intravenous or intramuscular use only. PACKAGE LABEL – PRINCIPAL DISPLAY - Midazolam 2 mL Blister Pack Label
  • PACKAGE LABEL – PRINCIPAL DISPLAY – Midazolam 2 mL Syringe Label 2mL Single-Dose. For IV or IM use Only. Rx only Midazolam Injection, USP CIV 2 mg/2 mL (1 mg/mL) Preservative Free PACKAGE LABEL – PRINCIPAL DISPLAY – Midazolam 2 mL Syringe Label
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 2mL Carton Panel Rx only NDC 76045-001-20 Midazolam Injection, USP CIV Preservative Free 2 mg / 2 mL (1 mg / mL) For Intravenous or Intramuscular use only. Do NOT place syringe on a Sterile Field. 24 X 2 mL Single-dose prefilled syringes Discard unused portion. ctn
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 2mL Blister Pack Label Rx only NDC 76045-001-00 Midazolam Injection, USP CIV 2 mg/2 mL (1 mg/mL) Preservative Free For intravenous or intramuscular use only. mat
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 2 mL Syringe Label 2 mL Single-Dose. For IV or IM Use Only. Rx only Midazolam Injection, USP CIV 2 mg/2 mL (1 mg/mL) Preservative Free syr
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 1mL Carton Panel Rx only NDC 76045-002-10 Midazolam Injection, USP CIV Preservative Free 5 mg / mL For Intravenous or Intramuscular Use Only. Do NOT place syringe on a Sterile Field. 24 X 1 mL Single-dose prefilled syringes Discard unused portion. PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 1mL Carton Panel
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 1 mL Blister Pack Label Rx only NDC 76045-002-00 Midazolam Injection, USP CIV Preservative Free 5 mg/mL For Intravenous or Intramuscular use only. PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 1 mL Blister Pack Label
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 1 mL Syringe Label 1 mL Single-Dose. For IV or IM Use Only. Midazolam Injection, USP CIV 5 mg/mL Preservative Free Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 1 mL Syringe Label
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 2mL Carton Panel Rx only NDC 76045-003-20 Midazolam Injection, USP CIV Preservative Free 10 mg / 2 mL (5 mg / mL) For Intravenous or Intramuscular use only. Do NOT place syringe on a Sterile Field. 24 X 2 mL Single-dose prefilled syringes Discard unused portion. PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 2mL Carton Panel
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 2 mL Blister Pack Label Rx only NDC 76045-003-00 Midazolam Injection, USP CIV 10 mg/2 mL (5 mg/mL) Preservative Free For intravenous or intramuscular use only. PACKAGE LABEL - PRINCIPAL DISPLAY – Midazolam 2 mL Blister Pack Label
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Midazolam 2 mL Syringe Label 2 mL Single-Dose. For IV or IM Use Only. Rx only Midazolam Injection, USP CIV 10 mg/2 mL (5 mg/mL) Preservative Free PACKAGE LABEL - PRINCIPAL DISPLAY - Midazolam 2 mL Syringe Label
source: label

Packages (0)

No package records.

Ingredients (1)

midazolam hydrochloride (10 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": [], "brand_name": "Midazolam", "product_id": "76045-003_ec9c9aee-b95f-4645-bf17-df7f1e3967d3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "76045-003", "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": "10 mg/2mL"}], "application_number": "ANDA203460", "marketing_category": "ANDA", "marketing_start_date": "20141003", "listing_expiration_date": "20261231"}