temazepam

Generic: temazepam

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

temazepam 7.5 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6436
Product ID 0904-6436_03705b1b-d68d-44b6-9ac4-5bacb01dacf7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071457
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2015-03-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046436
Hyphenated Format 0904-6436

Supplemental Identifiers

RxCUI
198243
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
  • 30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6436-04 30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK

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": "03705b1b-d68d-44b6-9ac4-5bacb01dacf7", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198243"], "spl_set_id": ["2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-6436-04)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-6436-04", "marketing_start_date": "20150325"}], "brand_name": "Temazepam", "product_id": "0904-6436_03705b1b-d68d-44b6-9ac4-5bacb01dacf7", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0904-6436", "dea_schedule": "CIV", "generic_name": "Temazepam", "labeler_name": "Major Pharmaceuticals", "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": "20150325", "listing_expiration_date": "20261231"}