midazolam

Generic: midazolam

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam
Generic Name midazolam
Labeler micro labs limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

midazolam hydrochloride 5 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-415
Product ID 42571-415_03a665f9-f328-83d4-e063-6294a90a756a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217504
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571415
Hyphenated Format 42571-415

Supplemental Identifiers

RxCUI
1666798 1666814 1666823
UPC
0342571415754 0342571415549 0342571415914 0342571415723 0342571414757
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 (source: ndc)
Application Number ANDA217504 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (42571-415-72) / 1 mL in 1 VIAL (42571-415-54)
  • 10 VIAL in 1 CARTON (42571-415-91) / 2 mL in 1 VIAL (42571-415-75)
source: ndc

Packages (2)

42571-415-72 10 VIAL in 1 CARTON (42571-415-72) / 1 mL in 1 VIAL (42571-415-54) 42571-415-91 10 VIAL in 1 CARTON (42571-415-91) / 2 mL in 1 VIAL (42571-415-75)

Ingredients (1)

midazolam hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Midazolam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "03a665f9-f328-83d4-e063-6294a90a756a", "openfda": {"upc": ["0342571415754", "0342571415549", "0342571415914", "0342571415723", "0342571414757"], "unii": ["W7TTW573JJ"], "rxcui": ["1666798", "1666814", "1666823"], "spl_set_id": ["9221894f-d840-46f2-a11c-6b71358d3b5b"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (42571-415-72)  / 1 mL in 1 VIAL (42571-415-54)", "package_ndc": "42571-415-72", "marketing_start_date": "20240101"}, {"sample": false, "description": "10 VIAL in 1 CARTON (42571-415-91)  / 2 mL in 1 VIAL (42571-415-75)", "package_ndc": "42571-415-91", "marketing_start_date": "20240101"}], "brand_name": "Midazolam", "product_id": "42571-415_03a665f9-f328-83d4-e063-6294a90a756a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "42571-415", "dea_schedule": "CIV", "generic_name": "Midazolam", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA217504", "marketing_category": "ANDA", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}