lorazepam

Generic: lorazepam

Labeler: pharmpak, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler pharmpak, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lorazepam 1 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-049
Product ID 54348-049_43401437-96cf-aa9c-e063-6394a90aedd6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078203
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-07-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54348049
Hyphenated Format 54348-049

Supplemental Identifiers

RxCUI
197901
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 ANDA078203 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-049-01) / 1 TABLET in 1 BOTTLE
source: ndc

Packages (1)

54348-049-01 1 BOTTLE in 1 BOX (54348-049-01) / 1 TABLET in 1 BOTTLE

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": "43401437-96cf-aa9c-e063-6394a90aedd6", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["197901"], "spl_set_id": ["b6e4d2c7-10c0-4d77-be7b-caa3d3b86997"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-049-01)  / 1 TABLET in 1 BOTTLE", "package_ndc": "54348-049-01", "marketing_start_date": "20190711"}], "brand_name": "Lorazepam", "product_id": "54348-049_43401437-96cf-aa9c-e063-6394a90aedd6", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "54348-049", "dea_schedule": "CIV", "generic_name": "LORAZEPAM", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": "1 mg/1"}], "application_number": "ANDA078203", "marketing_category": "ANDA", "marketing_start_date": "20190711", "listing_expiration_date": "20261231"}