lorazepam

Generic: lorazepam

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lorazepam 2 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-768
Product ID 71610-768_0ce251c7-bba3-45c9-aa24-6b7c6007b13a
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 71610768
Hyphenated Format 71610-768

Supplemental Identifiers

RxCUI
197902
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
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-768-30)
  • 60 TABLET in 1 BOTTLE (71610-768-53)
  • 90 TABLET in 1 BOTTLE (71610-768-60)
  • 120 TABLET in 1 BOTTLE (71610-768-70)
source: ndc

Packages (4)

71610-768-30 30 TABLET in 1 BOTTLE (71610-768-30) 71610-768-53 60 TABLET in 1 BOTTLE (71610-768-53) 71610-768-60 90 TABLET in 1 BOTTLE (71610-768-60) 71610-768-70 120 TABLET in 1 BOTTLE (71610-768-70)

Ingredients (1)

lorazepam (2 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": "0ce251c7-bba3-45c9-aa24-6b7c6007b13a", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["197902"], "spl_set_id": ["82f79757-69f0-4a37-93a6-55b66ae86ad7"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-768-30)", "package_ndc": "71610-768-30", "marketing_start_date": "20240205"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-768-53)", "package_ndc": "71610-768-53", "marketing_start_date": "20240109"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-768-60)", "package_ndc": "71610-768-60", "marketing_start_date": "20240205"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-768-70)", "package_ndc": "71610-768-70", "marketing_start_date": "20240109"}], "brand_name": "Lorazepam", "product_id": "71610-768_0ce251c7-bba3-45c9-aa24-6b7c6007b13a", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-768", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": "2 mg/1"}], "application_number": "ANDA076045", "marketing_category": "ANDA", "marketing_start_date": "20230625", "listing_expiration_date": "20261231"}