temazepam

Generic: temazepam

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 30 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-497
Product ID 63187-497_f2a9b002-a1ee-49e1-8477-0eb89fdbf1de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071457
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1987-04-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187497
Hyphenated Format 63187-497

Supplemental Identifiers

RxCUI
198242
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 ANDA071457 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (63187-497-00)
  • 30 CAPSULE in 1 BOTTLE (63187-497-30)
  • 60 CAPSULE in 1 BOTTLE (63187-497-60)
  • 90 CAPSULE in 1 BOTTLE (63187-497-90)
source: ndc

Packages (4)

63187-497-00 100 CAPSULE in 1 BOTTLE (63187-497-00) 63187-497-30 30 CAPSULE in 1 BOTTLE (63187-497-30) 63187-497-60 60 CAPSULE in 1 BOTTLE (63187-497-60) 63187-497-90 90 CAPSULE in 1 BOTTLE (63187-497-90)

Ingredients (1)

temazepam (30 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": "f2a9b002-a1ee-49e1-8477-0eb89fdbf1de", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198242"], "spl_set_id": ["5aaf8c99-cd58-47fc-8bf5-1039a6315ca5"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (63187-497-00)", "package_ndc": "63187-497-00", "marketing_start_date": "20190101"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (63187-497-30)", "package_ndc": "63187-497-30", "marketing_start_date": "20190101"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (63187-497-60)", "package_ndc": "63187-497-60", "marketing_start_date": "20190101"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (63187-497-90)", "package_ndc": "63187-497-90", "marketing_start_date": "20190101"}], "brand_name": "temazepam", "product_id": "63187-497_f2a9b002-a1ee-49e1-8477-0eb89fdbf1de", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "63187-497", "dea_schedule": "CIV", "generic_name": "temazepam", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "temazepam", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "30 mg/1"}], "application_number": "ANDA071457", "marketing_category": "ANDA", "marketing_start_date": "19870421", "listing_expiration_date": "20261231"}