lorazepam

Generic: lorazepam

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

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
ORAL
Active Ingredients

lorazepam 2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3532
Product ID 0054-3532_a0e90170-76ad-4493-991c-551903b42b09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072755
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1991-06-28

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00543532
Hyphenated Format 0054-3532

Supplemental Identifiers

RxCUI
311376
UNII
O26FZP769L
NUI
N0000175694 M0002356

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 lorazepam (source: ndc)
Generic Name lorazepam (source: ndc)
Application Number ANDA072755 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0054-3532-44) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

0054-3532-44 1 BOTTLE in 1 CARTON (0054-3532-44) / 30 mL in 1 BOTTLE

Ingredients (1)

lorazepam (2 mg/mL)

Linked Drug Pages (1)

Lorazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a0e90170-76ad-4493-991c-551903b42b09", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["311376"], "spl_set_id": ["5ff82103-cc57-4af9-9362-82a7c686271d"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0054-3532-44)  / 30 mL in 1 BOTTLE", "package_ndc": "0054-3532-44", "marketing_start_date": "19910628"}], "brand_name": "Lorazepam", "product_id": "0054-3532_a0e90170-76ad-4493-991c-551903b42b09", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0054-3532", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": "2 mg/mL"}], "application_number": "ANDA072755", "marketing_category": "ANDA", "marketing_start_date": "19910628", "listing_expiration_date": "20261231"}