midazolam

Generic: midazolam hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam
Generic Name midazolam hydrochloride
Labeler somerset therapeutics, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

midazolam hydrochloride 2 mg/2mL

Manufacturer
SOMERSET THERAPEUTICS, LLC

Identifiers & Regulatory

Product NDC 70069-816
Product ID 70069-816_0bbe4e90-4c26-cbbb-e063-6294a90aad1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090315
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-12-05

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069816
Hyphenated Format 70069-816

Supplemental Identifiers

RxCUI
1666798 1666800
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 ANDA090315 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/2mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (70069-816-10) / 2 mL in 1 VIAL
  • 25 VIAL in 1 CARTON (70069-816-25) / 2 mL in 1 VIAL
source: ndc

Packages (2)

70069-816-10 10 VIAL in 1 CARTON (70069-816-10) / 2 mL in 1 VIAL 70069-816-25 25 VIAL in 1 CARTON (70069-816-25) / 2 mL in 1 VIAL

Ingredients (1)

midazolam hydrochloride (2 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": "0bbe4e90-4c26-cbbb-e063-6294a90aad1b", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["1666798", "1666800"], "spl_set_id": ["74666098-1ca8-4c06-8fc4-5de870b1b514"], "manufacturer_name": ["SOMERSET THERAPEUTICS, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (70069-816-10)  / 2 mL in 1 VIAL", "package_ndc": "70069-816-10", "marketing_start_date": "20231205"}, {"sample": false, "description": "25 VIAL in 1 CARTON (70069-816-25)  / 2 mL in 1 VIAL", "package_ndc": "70069-816-25", "marketing_start_date": "20231205"}], "brand_name": "Midazolam", "product_id": "70069-816_0bbe4e90-4c26-cbbb-e063-6294a90aad1b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "70069-816", "dea_schedule": "CIV", "generic_name": "midazolam hydrochloride", "labeler_name": "SOMERSET THERAPEUTICS, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "2 mg/2mL"}], "application_number": "ANDA090315", "marketing_category": "ANDA", "marketing_start_date": "20231205", "listing_expiration_date": "20261231"}