temazepam

Generic: temazepam

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler actavis pharma, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 30 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-2077
Product ID 0228-2077_3050ee1e-c494-48ce-be40-6424e9661d87
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071620
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1990-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02282077
Hyphenated Format 0228-2077

Supplemental Identifiers

RxCUI
198241 198242
UPC
0302282076101
UNII
CHB1QD2QSS
NUI
N0000175694 M0002356

Packaging Origin

Original Packager
true

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 ANDA071620 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0228-2077-10)
  • 500 CAPSULE in 1 BOTTLE (0228-2077-50)
source: ndc

Packages (2)

0228-2077-10 100 CAPSULE in 1 BOTTLE (0228-2077-10) 0228-2077-50 500 CAPSULE in 1 BOTTLE (0228-2077-50)

Ingredients (1)

temazepam (30 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": "3050ee1e-c494-48ce-be40-6424e9661d87", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0302282076101"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242"], "spl_set_id": ["a4370eb4-b00d-4247-af8d-980e59fbbec6"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0228-2077-10)", "package_ndc": "0228-2077-10", "marketing_start_date": "19900930"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (0228-2077-50)", "package_ndc": "0228-2077-50", "marketing_start_date": "19900930"}], "brand_name": "Temazepam", "product_id": "0228-2077_3050ee1e-c494-48ce-be40-6424e9661d87", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0228-2077", "dea_schedule": "CIV", "generic_name": "Temazepam", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temazepam", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "30 mg/1"}], "application_number": "ANDA071620", "marketing_category": "ANDA", "marketing_start_date": "19900930", "listing_expiration_date": "20261231"}