lorazepam

Generic: lorazepam

Labeler: aurolife pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler aurolife pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lorazepam 1 mg/1

Manufacturer
Aurolife Pharma LLC

Identifiers & Regulatory

Product NDC 13107-084
Product ID 13107-084_67012944-0947-4e64-adab-869993f2f709
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203572
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107084
Hyphenated Format 13107-084

Supplemental Identifiers

RxCUI
197900 197901 197902
UPC
0313107083013 0313107084010 0313107085017
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 ANDA203572 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13107-084-01)
  • 500 TABLET in 1 BOTTLE (13107-084-05)
  • 10 TABLET in 1 BOTTLE (13107-084-10)
  • 1000 TABLET in 1 BOTTLE (13107-084-99)
source: ndc

Packages (4)

13107-084-01 100 TABLET in 1 BOTTLE (13107-084-01) 13107-084-05 500 TABLET in 1 BOTTLE (13107-084-05) 13107-084-10 10 TABLET in 1 BOTTLE (13107-084-10) 13107-084-99 1000 TABLET in 1 BOTTLE (13107-084-99)

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": "67012944-0947-4e64-adab-869993f2f709", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0313107083013", "0313107084010", "0313107085017"], "unii": ["O26FZP769L"], "rxcui": ["197900", "197901", "197902"], "spl_set_id": ["5b851f67-309d-4ef3-8b4b-ade8908256ea"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aurolife Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-084-01)", "package_ndc": "13107-084-01", "marketing_start_date": "20210201"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (13107-084-05)", "package_ndc": "13107-084-05", "marketing_start_date": "20210201"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (13107-084-10)", "package_ndc": "13107-084-10", "marketing_start_date": "20210201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13107-084-99)", "package_ndc": "13107-084-99", "marketing_start_date": "20210201"}], "brand_name": "LORAZEPAM", "product_id": "13107-084_67012944-0947-4e64-adab-869993f2f709", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "13107-084", "dea_schedule": "CIV", "generic_name": "LORAZEPAM", "labeler_name": "Aurolife Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LORAZEPAM", "active_ingredients": [{"name": "LORAZEPAM", "strength": "1 mg/1"}], "application_number": "ANDA203572", "marketing_category": "ANDA", "marketing_start_date": "20210201", "listing_expiration_date": "20261231"}