midazolam hydrochloride

Generic: midazolam hydrochloride

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

midazolam hydrochloride 5 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9916
Product ID 0404-9916_cf4854ec-c2d6-486d-9712-ffe9dac99926
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075857
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2022-01-17

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049916
Hyphenated Format 0404-9916

Supplemental Identifiers

RxCUI
1666814 1666823
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 hydrochloride (source: ndc)
Generic Name midazolam hydrochloride (source: ndc)
Application Number ANDA075857 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-01) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-02) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

0404-9916-01 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-01) / 1 mL in 1 VIAL, SINGLE-DOSE 0404-9916-02 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-02) / 2 mL in 1 VIAL, SINGLE-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": "cf4854ec-c2d6-486d-9712-ffe9dac99926", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["1666814", "1666823"], "spl_set_id": ["9e3bd5d3-36b3-471c-b8cc-ef48645700c2"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9916-01", "marketing_start_date": "20220117"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-02)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9916-02", "marketing_start_date": "20220117"}], "brand_name": "Midazolam Hydrochloride", "product_id": "0404-9916_cf4854ec-c2d6-486d-9712-ffe9dac99926", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0404-9916", "dea_schedule": "CIV", "generic_name": "Midazolam Hydrochloride", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam Hydrochloride", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA075857", "marketing_category": "ANDA", "marketing_start_date": "20220117", "listing_expiration_date": "20261231"}