midazolam hydrochloride

Generic: midazolam hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam hydrochloride
Generic Name midazolam hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

midazolam hydrochloride 5 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-108
Product ID 68083-108_3b7a93cb-a43a-46d0-ad52-6fba91da232d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090850
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2012-06-01

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083108
Hyphenated Format 68083-108

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 (68083-108-01) / 5 mL in 1 VIAL, MULTI-DOSE
  • 10 VIAL, MULTI-DOSE in 1 CARTON (68083-108-02) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

68083-108-01 10 VIAL, MULTI-DOSE in 1 CARTON (68083-108-01) / 5 mL in 1 VIAL, MULTI-DOSE 68083-108-02 10 VIAL, MULTI-DOSE in 1 CARTON (68083-108-02) / 10 mL in 1 VIAL, MULTI-DOSE

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": "3b7a93cb-a43a-46d0-ad52-6fba91da232d", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["311702"], "spl_set_id": ["81b2f48d-a05c-4301-8fee-761af220d44f"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (68083-108-01)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-108-01", "marketing_start_date": "20120601"}, {"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (68083-108-02)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-108-02", "marketing_start_date": "20120601"}], "brand_name": "Midazolam Hydrochloride", "product_id": "68083-108_3b7a93cb-a43a-46d0-ad52-6fba91da232d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "68083-108", "dea_schedule": "CIV", "generic_name": "Midazolam Hydrochloride", "labeler_name": "Gland Pharma Limited", "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": "20120601", "listing_expiration_date": "20261231"}