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 5 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-412
Product ID 63323-412_9814447b-a93e-42ad-b57e-5db0a5b7f552
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075154
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2000-07-10

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323412
Hyphenated Format 63323-412

Supplemental Identifiers

RxCUI
311700 311702
UPC
0363323411183 0363323411138 0363323412135 0363323411220 0363323412180 0363323412036 0363323411152
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 ANDA075154 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (63323-412-02) / 2 mL in 1 VIAL (63323-412-03)
  • 10 VIAL in 1 TRAY (63323-412-10) / 10 mL in 1 VIAL (63323-412-13)
  • 25 VIAL in 1 TRAY (63323-412-25) / 1 mL in 1 VIAL (63323-412-18)
source: ndc

Packages (3)

63323-412-02 10 VIAL in 1 TRAY (63323-412-02) / 2 mL in 1 VIAL (63323-412-03) 63323-412-10 10 VIAL in 1 TRAY (63323-412-10) / 10 mL in 1 VIAL (63323-412-13) 63323-412-25 25 VIAL in 1 TRAY (63323-412-25) / 1 mL in 1 VIAL (63323-412-18)

Ingredients (1)

midazolam hydrochloride (5 mg/mL)

Linked Drug Pages (2)

Midazolam ndc-match (0.9) Midazolam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "9814447b-a93e-42ad-b57e-5db0a5b7f552", "openfda": {"upc": ["0363323411183", "0363323411138", "0363323412135", "0363323411220", "0363323412180", "0363323412036", "0363323411152"], "unii": ["W7TTW573JJ"], "rxcui": ["311700", "311702"], "spl_set_id": ["a91ce254-14a3-4cbf-8ab8-5da252aa3fdc"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (63323-412-02)  / 2 mL in 1 VIAL (63323-412-03)", "package_ndc": "63323-412-02", "marketing_start_date": "20000710"}, {"sample": false, "description": "10 VIAL in 1 TRAY (63323-412-10)  / 10 mL in 1 VIAL (63323-412-13)", "package_ndc": "63323-412-10", "marketing_start_date": "20000710"}, {"sample": false, "description": "25 VIAL in 1 TRAY (63323-412-25)  / 1 mL in 1 VIAL (63323-412-18)", "package_ndc": "63323-412-25", "marketing_start_date": "20000710"}], "brand_name": "Midazolam", "product_id": "63323-412_9814447b-a93e-42ad-b57e-5db0a5b7f552", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "63323-412", "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": "5 mg/mL"}], "application_number": "ANDA075154", "marketing_category": "ANDA", "marketing_start_date": "20000710", "listing_expiration_date": "20261231"}