midazolam

Generic: midazolam hydrochloride

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

Drug Facts

Product Profile

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

midazolam hydrochloride 2 mg/2mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4328
Product ID 70518-4328_402f646b-1f17-d819-e063-6394a90ab1d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090315
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-04-14

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184328
Hyphenated Format 70518-4328

Supplemental Identifiers

RxCUI
1666798
UNII
W7TTW573JJ

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 (70518-4328-0) / 2 mL in 1 VIAL (70518-4328-1)
source: ndc

Packages (1)

70518-4328-0 10 VIAL in 1 CARTON (70518-4328-0) / 2 mL in 1 VIAL (70518-4328-1)

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": "402f646b-1f17-d819-e063-6394a90ab1d8", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["1666798"], "spl_set_id": ["d9305142-417d-4d8c-9a23-f9a1b6771cac"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (70518-4328-0)  / 2 mL in 1 VIAL (70518-4328-1)", "package_ndc": "70518-4328-0", "marketing_start_date": "20250414"}], "brand_name": "Midazolam", "product_id": "70518-4328_402f646b-1f17-d819-e063-6394a90ab1d8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "70518-4328", "dea_schedule": "CIV", "generic_name": "midazolam hydrochloride", "labeler_name": "REMEDYREPACK INC.", "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": "20250414", "listing_expiration_date": "20261231"}