midazolam in sodium chloride

Generic: midazolam in sodium chloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam in sodium chloride
Generic Name midazolam in sodium chloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

midazolam hydrochloride 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9379
Product ID 0143-9379_a6be32fe-dc3d-4ce0-b780-8ba6b4261acc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216159
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-05-19

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439379
Hyphenated Format 0143-9379

Supplemental Identifiers

RxCUI
2541170 2541171
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 in sodium chloride (source: ndc)
Generic Name midazolam in sodium chloride (source: ndc)
Application Number ANDA216159 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (0143-9379-10) / 1 BAG in 1 POUCH (0143-9379-01) / 50 mL in 1 BAG
source: ndc

Packages (1)

0143-9379-10 10 POUCH in 1 CARTON (0143-9379-10) / 1 BAG in 1 POUCH (0143-9379-01) / 50 mL in 1 BAG

Ingredients (1)

midazolam hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Midazolam in Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a6be32fe-dc3d-4ce0-b780-8ba6b4261acc", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["2541170", "2541171"], "spl_set_id": ["4155a60a-b023-4f4a-acae-7bb8fe9dc0c1"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (0143-9379-10)  / 1 BAG in 1 POUCH (0143-9379-01)  / 50 mL in 1 BAG", "package_ndc": "0143-9379-10", "marketing_start_date": "20230519"}], "brand_name": "Midazolam in Sodium Chloride", "product_id": "0143-9379_a6be32fe-dc3d-4ce0-b780-8ba6b4261acc", "dosage_form": "INJECTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0143-9379", "dea_schedule": "CIV", "generic_name": "Midazolam in Sodium Chloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam in Sodium Chloride", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA216159", "marketing_category": "ANDA", "marketing_start_date": "20230519", "listing_expiration_date": "20261231"}