temazepam

Generic: temazepam

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 15 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-779
Product ID 50268-779_2b4d448a-1ee3-fe11-e063-6394a90a2537
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071456
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-10-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268779
Hyphenated Format 50268-779

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
  • 50 BLISTER PACK in 1 BOX (50268-779-15) / 1 CAPSULE in 1 BLISTER PACK (50268-779-11)
source: ndc

Packages (1)

50268-779-15 50 BLISTER PACK in 1 BOX (50268-779-15) / 1 CAPSULE in 1 BLISTER PACK (50268-779-11)

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": "2b4d448a-1ee3-fe11-e063-6394a90a2537", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242"], "spl_set_id": ["08183adb-af12-fcb2-e063-6394a90afea4"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-779-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-779-11)", "package_ndc": "50268-779-15", "marketing_start_date": "20231019"}], "brand_name": "temazepam", "product_id": "50268-779_2b4d448a-1ee3-fe11-e063-6394a90a2537", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "50268-779", "dea_schedule": "CIV", "generic_name": "temazepam", "labeler_name": "AvPAK", "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": "20231019", "listing_expiration_date": "20261231"}