temazepam

Generic: temazepam

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA 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 43353-312
Product ID 43353-312_ec1b0a54-5f93-45ed-bbbf-0bf3cd42ba73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071456
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 43353312
Hyphenated Format 43353-312

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 ANDA071456 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE (43353-312-10)
  • 15 CAPSULE in 1 BOTTLE (43353-312-15)
  • 28 CAPSULE in 1 BOTTLE (43353-312-28)
  • 30 CAPSULE in 1 BOTTLE (43353-312-30)
  • 45 CAPSULE in 1 BOTTLE (43353-312-45)
  • 60 CAPSULE in 1 BOTTLE (43353-312-53)
  • 90 CAPSULE in 1 BOTTLE (43353-312-60)
source: ndc

Packages (7)

43353-312-10 10 CAPSULE in 1 BOTTLE (43353-312-10) 43353-312-15 15 CAPSULE in 1 BOTTLE (43353-312-15) 43353-312-28 28 CAPSULE in 1 BOTTLE (43353-312-28) 43353-312-30 30 CAPSULE in 1 BOTTLE (43353-312-30) 43353-312-45 45 CAPSULE in 1 BOTTLE (43353-312-45) 43353-312-53 60 CAPSULE in 1 BOTTLE (43353-312-53) 43353-312-60 90 CAPSULE in 1 BOTTLE (43353-312-60)

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": "ec1b0a54-5f93-45ed-bbbf-0bf3cd42ba73", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242"], "spl_set_id": ["b2422ca0-2f06-419f-aa0e-88c556b62399"], "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 (43353-312-10)", "package_ndc": "43353-312-10", "marketing_start_date": "20180627"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE (43353-312-15)", "package_ndc": "43353-312-15", "marketing_start_date": "20170921"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (43353-312-28)", "package_ndc": "43353-312-28", "marketing_start_date": "20180627"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (43353-312-30)", "package_ndc": "43353-312-30", "marketing_start_date": "20170501"}, {"sample": false, "description": "45 CAPSULE in 1 BOTTLE (43353-312-45)", "package_ndc": "43353-312-45", "marketing_start_date": "20170921"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (43353-312-53)", "package_ndc": "43353-312-53", "marketing_start_date": "20170501"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (43353-312-60)", "package_ndc": "43353-312-60", "marketing_start_date": "20170501"}], "brand_name": "temazepam", "product_id": "43353-312_ec1b0a54-5f93-45ed-bbbf-0bf3cd42ba73", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "43353-312", "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": "ANDA071456", "marketing_category": "ANDA", "marketing_start_date": "19870421", "listing_expiration_date": "20261231"}