temazepam

Generic: temazepam

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 15 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0191
Product ID 80425-0191_2a99a670-af37-299d-e063-6294a90a05d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071456
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2022-06-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250191
Hyphenated Format 80425-0191

Supplemental Identifiers

RxCUI
198241
UNII
CHB1QD2QSS
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 temazepam (source: ndc)
Generic Name temazepam (source: ndc)
Application Number ANDA071456 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 20 CAPSULE in 1 BOTTLE (80425-0191-1)
  • 30 CAPSULE in 1 BOTTLE (80425-0191-2)
source: ndc

Packages (2)

80425-0191-1 20 CAPSULE in 1 BOTTLE (80425-0191-1) 80425-0191-2 30 CAPSULE in 1 BOTTLE (80425-0191-2)

Ingredients (1)

temazepam (15 mg/1)

Linked Drug Pages (1)

Temazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a99a670-af37-299d-e063-6294a90a05d2", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241"], "spl_set_id": ["d83e14ae-9823-e57b-e053-2a95a90a8524"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE in 1 BOTTLE (80425-0191-1)", "package_ndc": "80425-0191-1", "marketing_start_date": "20240217"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (80425-0191-2)", "package_ndc": "80425-0191-2", "marketing_start_date": "20230330"}], "brand_name": "Temazepam", "product_id": "80425-0191_2a99a670-af37-299d-e063-6294a90a05d2", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "80425-0191", "dea_schedule": "CIV", "generic_name": "Temazepam", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temazepam", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "15 mg/1"}], "application_number": "ANDA071456", "marketing_category": "ANDA", "marketing_start_date": "20220614", "listing_expiration_date": "20261231"}