midazolam

Generic: midazolam hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam
Generic Name midazolam hydrochloride
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

midazolam hydrochloride 5 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-661
Product ID 25021-661_002ea282-09ba-4d79-8bd1-94c9859f442b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090850
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2012-03-19

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021661
Hyphenated Format 25021-661

Supplemental Identifiers

RxCUI
311702
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 ANDA090850 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-661-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

25021-661-10 10 VIAL in 1 CARTON (25021-661-10) / 10 mL in 1 VIAL

Ingredients (1)

midazolam hydrochloride (5 mg/mL)

Linked Drug Pages (1)

midazolam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "002ea282-09ba-4d79-8bd1-94c9859f442b", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["311702"], "spl_set_id": ["880cac48-5c0f-49a9-8aef-3c9770bf5d84"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-661-10)  / 10 mL in 1 VIAL", "package_ndc": "25021-661-10", "marketing_start_date": "20120319"}], "brand_name": "midazolam", "product_id": "25021-661_002ea282-09ba-4d79-8bd1-94c9859f442b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "25021-661", "dea_schedule": "CIV", "generic_name": "midazolam hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "midazolam", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA090850", "marketing_category": "ANDA", "marketing_start_date": "20120319", "listing_expiration_date": "20261231"}