lorazepam

Generic: lorazepam

Labeler: sun pharmaceutical industries inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler sun pharmaceutical industries inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lorazepam .5 mg/1

Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC

Identifiers & Regulatory

Product NDC 63304-772
Product ID 63304-772_b8fbb599-96d9-4866-908d-d8be424e5ee3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076045
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-06-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304772
Hyphenated Format 63304-772

Supplemental Identifiers

RxCUI
197900 197901 197902
UPC
0363304772906 0363304774900 0363304773903
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 ANDA076045 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (63304-772-01)
  • 500 TABLET in 1 BOTTLE (63304-772-05)
  • 1000 TABLET in 1 BOTTLE (63304-772-10)
  • 90 TABLET in 1 BOTTLE (63304-772-90)
source: ndc

Packages (4)

63304-772-01 100 TABLET in 1 BOTTLE (63304-772-01) 63304-772-05 500 TABLET in 1 BOTTLE (63304-772-05) 63304-772-10 1000 TABLET in 1 BOTTLE (63304-772-10) 63304-772-90 90 TABLET in 1 BOTTLE (63304-772-90)

Ingredients (1)

lorazepam (.5 mg/1)

Linked Drug Pages (1)

Lorazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b8fbb599-96d9-4866-908d-d8be424e5ee3", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0363304772906", "0363304774900", "0363304773903"], "unii": ["O26FZP769L"], "rxcui": ["197900", "197901", "197902"], "spl_set_id": ["0c1caa9c-9ef1-459c-86c3-adb939130a9f"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["SUN PHARMACEUTICAL INDUSTRIES INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (63304-772-01)", "package_ndc": "63304-772-01", "marketing_start_date": "20230625"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (63304-772-05)", "package_ndc": "63304-772-05", "marketing_start_date": "20230625"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (63304-772-10)", "package_ndc": "63304-772-10", "marketing_start_date": "20230625"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63304-772-90)", "package_ndc": "63304-772-90", "marketing_start_date": "20230625"}], "brand_name": "Lorazepam", "product_id": "63304-772_b8fbb599-96d9-4866-908d-d8be424e5ee3", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "63304-772", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "SUN PHARMACEUTICAL INDUSTRIES INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": ".5 mg/1"}], "application_number": "ANDA076045", "marketing_category": "ANDA", "marketing_start_date": "20230625", "listing_expiration_date": "20261231"}