loreev xr

Generic: lorazepam

Labeler: almatica pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name loreev xr
Generic Name lorazepam
Labeler almatica pharma llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lorazepam 1 mg/1

Manufacturer
Almatica Pharma LLC

Identifiers & Regulatory

Product NDC 52427-658
Product ID 52427-658_1ce5f319-4e44-ae8e-b6be-ecf54a0d345a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214826
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-08-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52427658
Hyphenated Format 52427-658

Supplemental Identifiers

RxCUI
2569564 2569571 2569573 2569575 2569577 2569580 2594600 2594603
UPC
0352427663307 0352427658303 0352427667305 0352427661303
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 loreev xr (source: ndc)
Generic Name lorazepam (source: ndc)
Application Number NDA214826 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-658-30)
source: ndc

Packages (1)

52427-658-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-658-30)

Ingredients (1)

lorazepam (1 mg/1)

Linked Drug Pages (1)

LOREEV XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1ce5f319-4e44-ae8e-b6be-ecf54a0d345a", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0352427663307", "0352427658303", "0352427667305", "0352427661303"], "unii": ["O26FZP769L"], "rxcui": ["2569564", "2569571", "2569573", "2569575", "2569577", "2569580", "2594600", "2594603"], "spl_set_id": ["227734c1-bf01-9607-73ea-5a1f38a89bd9"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Almatica Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-658-30)", "package_ndc": "52427-658-30", "marketing_start_date": "20210924"}], "brand_name": "LOREEV XR", "product_id": "52427-658_1ce5f319-4e44-ae8e-b6be-ecf54a0d345a", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "52427-658", "dea_schedule": "CIV", "generic_name": "lorazepam", "labeler_name": "Almatica Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LOREEV XR", "active_ingredients": [{"name": "LORAZEPAM", "strength": "1 mg/1"}], "application_number": "NDA214826", "marketing_category": "NDA", "marketing_start_date": "20210831", "listing_expiration_date": "20261231"}