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 67544-136
Product ID 67544-136_6d75ac66-4a65-487b-a938-7414907c2632
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071638
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1987-08-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67544136
Hyphenated Format 67544-136

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 ANDA071638 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-10)
  • 14 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-14)
  • 15 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-15)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-20)
  • 28 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-28)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-30)
  • 45 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-45)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-53)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-60)
source: ndc

Packages (9)

67544-136-10 10 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-10) 67544-136-14 14 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-14) 67544-136-15 15 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-15) 67544-136-20 20 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-20) 67544-136-28 28 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-28) 67544-136-30 30 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-30) 67544-136-45 45 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-45) 67544-136-53 60 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-53) 67544-136-60 90 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-60)

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": "6d75ac66-4a65-487b-a938-7414907c2632", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242"], "spl_set_id": ["2461dfbd-5704-42f4-bde7-d1461811d898"], "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, PLASTIC (67544-136-10)", "package_ndc": "67544-136-10", "marketing_start_date": "20040826"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-14)", "package_ndc": "67544-136-14", "marketing_start_date": "20040826"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-15)", "package_ndc": "67544-136-15", "marketing_start_date": "20040916"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-20)", "package_ndc": "67544-136-20", "marketing_start_date": "20040901"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-28)", "package_ndc": "67544-136-28", "marketing_start_date": "20090830"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-30)", "package_ndc": "67544-136-30", "marketing_start_date": "20041016"}, {"sample": false, "description": "45 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-45)", "package_ndc": "67544-136-45", "marketing_start_date": "20040901"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-53)", "package_ndc": "67544-136-53", "marketing_start_date": "20041016"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-60)", "package_ndc": "67544-136-60", "marketing_start_date": "20041208"}], "brand_name": "Temazepam", "product_id": "67544-136_6d75ac66-4a65-487b-a938-7414907c2632", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "67544-136", "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": "ANDA071638", "marketing_category": "ANDA", "marketing_start_date": "19870803", "listing_expiration_date": "20261231"}