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 15 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-914
Product ID 71205-914_40b473bd-d806-4631-a7ff-58ccc51fd201
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 71205914
Hyphenated Format 71205-914

Supplemental Identifiers

RxCUI
198241 198242
UPC
0371205915308 0371205914301
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
  • 100 CAPSULE in 1 BOTTLE (71205-914-00)
  • 30 CAPSULE in 1 BOTTLE (71205-914-30)
  • 500 CAPSULE in 1 BOTTLE (71205-914-55)
  • 60 CAPSULE in 1 BOTTLE (71205-914-60)
  • 120 CAPSULE in 1 BOTTLE (71205-914-72)
  • 90 CAPSULE in 1 BOTTLE (71205-914-90)
source: ndc

Packages (6)

71205-914-00 100 CAPSULE in 1 BOTTLE (71205-914-00) 71205-914-30 30 CAPSULE in 1 BOTTLE (71205-914-30) 71205-914-55 500 CAPSULE in 1 BOTTLE (71205-914-55) 71205-914-60 60 CAPSULE in 1 BOTTLE (71205-914-60) 71205-914-72 120 CAPSULE in 1 BOTTLE (71205-914-72) 71205-914-90 90 CAPSULE in 1 BOTTLE (71205-914-90)

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": "40b473bd-d806-4631-a7ff-58ccc51fd201", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0371205915308", "0371205914301"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242"], "spl_set_id": ["ccf04879-3ad5-4fc3-89f5-879c97887017"], "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 (71205-914-00)", "package_ndc": "71205-914-00", "marketing_start_date": "20210714"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71205-914-30)", "package_ndc": "71205-914-30", "marketing_start_date": "20210714"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (71205-914-55)", "package_ndc": "71205-914-55", "marketing_start_date": "20210714"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71205-914-60)", "package_ndc": "71205-914-60", "marketing_start_date": "20210714"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71205-914-72)", "package_ndc": "71205-914-72", "marketing_start_date": "20210714"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71205-914-90)", "package_ndc": "71205-914-90", "marketing_start_date": "20210714"}], "brand_name": "temazepam", "product_id": "71205-914_40b473bd-d806-4631-a7ff-58ccc51fd201", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71205-914", "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": "15 mg/1"}], "application_number": "ANDA071456", "marketing_category": "ANDA", "marketing_start_date": "19870421", "listing_expiration_date": "20261231"}