midazolam hydrochloride

Generic: midazolam hydrochloride

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam hydrochloride
Generic Name midazolam hydrochloride
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

midazolam hydrochloride 5 mg/mL

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-601
Product ID 23155-601_e20feff9-3aca-4bc1-a5c3-44fff8a9459c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090850
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2016-11-07

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155601
Hyphenated Format 23155-601

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 hydrochloride (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, MULTI-DOSE in 1 CARTON (23155-601-41) / 5 mL in 1 VIAL, MULTI-DOSE (23155-601-31)
  • 10 VIAL, MULTI-DOSE in 1 CARTON (23155-601-42) / 10 mL in 1 VIAL, MULTI-DOSE (23155-601-32)
source: ndc

Packages (2)

23155-601-41 10 VIAL, MULTI-DOSE in 1 CARTON (23155-601-41) / 5 mL in 1 VIAL, MULTI-DOSE (23155-601-31) 23155-601-42 10 VIAL, MULTI-DOSE in 1 CARTON (23155-601-42) / 10 mL in 1 VIAL, MULTI-DOSE (23155-601-32)

Ingredients (1)

midazolam hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Midazolam hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "e20feff9-3aca-4bc1-a5c3-44fff8a9459c", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["311702"], "spl_set_id": ["843cc25e-45ea-4372-ae34-843f805fa869"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (23155-601-41)  / 5 mL in 1 VIAL, MULTI-DOSE (23155-601-31)", "package_ndc": "23155-601-41", "marketing_start_date": "20161107"}, {"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (23155-601-42)  / 10 mL in 1 VIAL, MULTI-DOSE (23155-601-32)", "package_ndc": "23155-601-42", "marketing_start_date": "20161107"}], "brand_name": "Midazolam hydrochloride", "product_id": "23155-601_e20feff9-3aca-4bc1-a5c3-44fff8a9459c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "23155-601", "dea_schedule": "CIV", "generic_name": "Midazolam hydrochloride", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam hydrochloride", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA090850", "marketing_category": "ANDA", "marketing_start_date": "20161107", "listing_expiration_date": "20261231"}