temazepam

Generic: temazepam

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 7.5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-472
Product ID 76420-472_40a62008-e0ba-4776-e063-6394a90a21a3
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 76420472
Hyphenated Format 76420-472

Supplemental Identifiers

RxCUI
198241 198242 198243 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
  • 7.5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (76420-472-01)
  • 500 CAPSULE in 1 BOTTLE (76420-472-05)
  • 30 CAPSULE in 1 BOTTLE (76420-472-30)
  • 60 CAPSULE in 1 BOTTLE (76420-472-60)
  • 90 CAPSULE in 1 BOTTLE (76420-472-90)
source: ndc

Packages (5)

76420-472-01 100 CAPSULE in 1 BOTTLE (76420-472-01) 76420-472-05 500 CAPSULE in 1 BOTTLE (76420-472-05) 76420-472-30 30 CAPSULE in 1 BOTTLE (76420-472-30) 76420-472-60 60 CAPSULE in 1 BOTTLE (76420-472-60) 76420-472-90 90 CAPSULE in 1 BOTTLE (76420-472-90)

Ingredients (1)

temazepam (7.5 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": "40a62008-e0ba-4776-e063-6394a90a21a3", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242", "198243", "485489"], "spl_set_id": ["254a0273-c0f3-4d2d-b18e-4ab51ba4bc50"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-472-01)", "package_ndc": "76420-472-01", "marketing_start_date": "20250918"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (76420-472-05)", "package_ndc": "76420-472-05", "marketing_start_date": "20250918"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-472-30)", "package_ndc": "76420-472-30", "marketing_start_date": "20250918"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-472-60)", "package_ndc": "76420-472-60", "marketing_start_date": "20250918"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-472-90)", "package_ndc": "76420-472-90", "marketing_start_date": "20250918"}], "brand_name": "temazepam", "product_id": "76420-472_40a62008-e0ba-4776-e063-6394a90a21a3", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "76420-472", "dea_schedule": "CIV", "generic_name": "temazepam", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "temazepam", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "7.5 mg/1"}], "application_number": "ANDA071457", "marketing_category": "ANDA", "marketing_start_date": "20120628", "listing_expiration_date": "20261231"}