midazolam

Generic: midazolam hydrochloride

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam
Generic Name midazolam hydrochloride
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

midazolam hydrochloride 5 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-2308
Product ID 0409-2308_8c3cf34b-901d-407a-946d-a1556bb24551
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075857
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2005-06-14

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04092308
Hyphenated Format 0409-2308

Supplemental Identifiers

RxCUI
1666798 1666800 1666814 1666823
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 ANDA075857 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2308-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2308-21)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2308-02) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-2308-22)
source: ndc

Packages (2)

0409-2308-01 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2308-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2308-21) 0409-2308-02 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2308-02) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-2308-22)

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": "8c3cf34b-901d-407a-946d-a1556bb24551", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["1666798", "1666800", "1666814", "1666823"], "spl_set_id": ["1abda8b8-48a8-4995-af86-39220d1aa240"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2308-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2308-21)", "package_ndc": "0409-2308-01", "marketing_start_date": "20050614"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2308-02)  / 2 mL in 1 VIAL, SINGLE-DOSE (0409-2308-22)", "package_ndc": "0409-2308-02", "marketing_start_date": "20051004"}], "brand_name": "Midazolam", "product_id": "0409-2308_8c3cf34b-901d-407a-946d-a1556bb24551", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0409-2308", "dea_schedule": "CIV", "generic_name": "MIDAZOLAM HYDROCHLORIDE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA075857", "marketing_category": "ANDA", "marketing_start_date": "20050614", "listing_expiration_date": "20261231"}