temazepam

Generic: temazepam

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 22.5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8604
Product ID 63629-8604_bb2354c0-ae61-4be3-bec7-fa29df33a100
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071457
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2012-06-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298604
Hyphenated Format 63629-8604

Supplemental Identifiers

RxCUI
485489
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
  • 22.5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (63629-8604-1)
source: ndc

Packages (1)

63629-8604-1 30 CAPSULE in 1 BOTTLE (63629-8604-1)

Ingredients (1)

temazepam (22.5 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": "bb2354c0-ae61-4be3-bec7-fa29df33a100", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["485489"], "spl_set_id": ["1e37d59b-b8be-46ef-8706-fffd563a8c15"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (63629-8604-1)", "package_ndc": "63629-8604-1", "marketing_start_date": "20210713"}], "brand_name": "temazepam", "product_id": "63629-8604_bb2354c0-ae61-4be3-bec7-fa29df33a100", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "63629-8604", "dea_schedule": "CIV", "generic_name": "temazepam", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "temazepam", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "22.5 mg/1"}], "application_number": "ANDA071457", "marketing_category": "ANDA", "marketing_start_date": "20120628", "listing_expiration_date": "20261231"}