midazolam

Generic: midazolam

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

Drug Facts

Product Profile

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

midazolam hydrochloride 5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6218
Product ID 0641-6218_c7078d4a-0f37-4305-b20c-0a8f17382963
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212847
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-03-29

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416218
Hyphenated Format 0641-6218

Supplemental Identifiers

RxCUI
998211 1551393 1551395
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 ANDA212847 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (0641-6218-10) / 1 mL in 1 SYRINGE (0641-6218-01)
source: ndc

Packages (1)

0641-6218-10 10 SYRINGE in 1 CARTON (0641-6218-10) / 1 mL in 1 SYRINGE (0641-6218-01)

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": "c7078d4a-0f37-4305-b20c-0a8f17382963", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["998211", "1551393", "1551395"], "spl_set_id": ["51c8bfa4-5c78-4b7a-9ffb-8f00828acadc"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (0641-6218-10)  / 1 mL in 1 SYRINGE (0641-6218-01)", "package_ndc": "0641-6218-10", "marketing_start_date": "20240329"}], "brand_name": "Midazolam", "product_id": "0641-6218_c7078d4a-0f37-4305-b20c-0a8f17382963", "dosage_form": "INJECTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0641-6218", "dea_schedule": "CIV", "generic_name": "Midazolam", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA212847", "marketing_category": "ANDA", "marketing_start_date": "20240329", "listing_expiration_date": "20261231"}