lorazepam

Generic: lorazepam

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lorazepam 1 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-356
Product ID 72789-356_3ba0f2b6-845e-8fdb-e063-6394a90a4502
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076045
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-10-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789356
Hyphenated Format 72789-356

Supplemental Identifiers

RxCUI
197900 197901 197902
UPC
0372789355900 0372789356952 0372789357904
UNII
O26FZP769L
NUI
N0000175694 M0002356

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
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (72789-356-01)
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-356-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (72789-356-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (72789-356-90)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (72789-356-95)
source: ndc

Packages (5)

72789-356-01 100 TABLET in 1 BOTTLE, PLASTIC (72789-356-01) 72789-356-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-356-30) 72789-356-60 60 TABLET in 1 BOTTLE, PLASTIC (72789-356-60) 72789-356-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-356-90) 72789-356-95 1000 TABLET in 1 BOTTLE, PLASTIC (72789-356-95)

Ingredients (1)

lorazepam (1 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": "3ba0f2b6-845e-8fdb-e063-6394a90a4502", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0372789355900", "0372789356952", "0372789357904"], "unii": ["O26FZP769L"], "rxcui": ["197900", "197901", "197902"], "spl_set_id": ["08a30230-fc95-9025-e063-6394a90ae21b"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (72789-356-01)", "package_ndc": "72789-356-01", "marketing_start_date": "20250505"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-356-30)", "package_ndc": "72789-356-30", "marketing_start_date": "20231026"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (72789-356-60)", "package_ndc": "72789-356-60", "marketing_start_date": "20231026"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (72789-356-90)", "package_ndc": "72789-356-90", "marketing_start_date": "20231026"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (72789-356-95)", "package_ndc": "72789-356-95", "marketing_start_date": "20231026"}], "brand_name": "Lorazepam", "product_id": "72789-356_3ba0f2b6-845e-8fdb-e063-6394a90a4502", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "72789-356", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": "1 mg/1"}], "application_number": "ANDA076045", "marketing_category": "ANDA", "marketing_start_date": "20231026", "listing_expiration_date": "20261231"}