temazepam

Generic: temazepam

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 15 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-625
Product ID 71610-625_1b2a670e-edfd-4ce9-e063-6294a90aaf23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018163
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2010-02-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610625
Hyphenated Format 71610-625

Supplemental Identifiers

RxCUI
198241 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 NDA018163 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE (71610-625-10)
  • 15 CAPSULE in 1 BOTTLE (71610-625-15)
  • 20 CAPSULE in 1 BOTTLE (71610-625-20)
  • 28 CAPSULE in 1 BOTTLE (71610-625-28)
  • 30 CAPSULE in 1 BOTTLE (71610-625-30)
  • 45 CAPSULE in 1 BOTTLE (71610-625-45)
  • 60 CAPSULE in 1 BOTTLE (71610-625-53)
  • 90 CAPSULE in 1 BOTTLE (71610-625-60)
source: ndc

Packages (8)

71610-625-10 10 CAPSULE in 1 BOTTLE (71610-625-10) 71610-625-15 15 CAPSULE in 1 BOTTLE (71610-625-15) 71610-625-20 20 CAPSULE in 1 BOTTLE (71610-625-20) 71610-625-28 28 CAPSULE in 1 BOTTLE (71610-625-28) 71610-625-30 30 CAPSULE in 1 BOTTLE (71610-625-30) 71610-625-45 45 CAPSULE in 1 BOTTLE (71610-625-45) 71610-625-53 60 CAPSULE in 1 BOTTLE (71610-625-53) 71610-625-60 90 CAPSULE in 1 BOTTLE (71610-625-60)

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": "1b2a670e-edfd-4ce9-e063-6294a90aaf23", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242"], "spl_set_id": ["a8deb28b-c5a3-4775-8bec-3f276698d064"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE (71610-625-10)", "package_ndc": "71610-625-10", "marketing_start_date": "20240614"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE (71610-625-15)", "package_ndc": "71610-625-15", "marketing_start_date": "20211210"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (71610-625-20)", "package_ndc": "71610-625-20", "marketing_start_date": "20240614"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (71610-625-28)", "package_ndc": "71610-625-28", "marketing_start_date": "20240614"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-625-30)", "package_ndc": "71610-625-30", "marketing_start_date": "20211210"}, {"sample": false, "description": "45 CAPSULE in 1 BOTTLE (71610-625-45)", "package_ndc": "71610-625-45", "marketing_start_date": "20211210"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-625-53)", "package_ndc": "71610-625-53", "marketing_start_date": "20211210"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-625-60)", "package_ndc": "71610-625-60", "marketing_start_date": "20211210"}], "brand_name": "TEMAZEPAM", "product_id": "71610-625_1b2a670e-edfd-4ce9-e063-6294a90aaf23", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-625", "dea_schedule": "CIV", "generic_name": "temazepam", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEMAZEPAM", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "15 mg/1"}], "application_number": "NDA018163", "marketing_category": "NDA", "marketing_start_date": "20100223", "listing_expiration_date": "20261231"}