temazepam

Generic: temazepam

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

temazepam 22.5 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-9959
Product ID 0406-9959_2794b069-e886-4191-9227-2b6c5e569b19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018163
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2010-02-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04069959
Hyphenated Format 0406-9959

Supplemental Identifiers

RxCUI
198241 198242 198243 485489
UPC
0304069960016 0304069962010 0304069961013
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 NDA018163 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 22.5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (0406-9959-03)
source: ndc

Packages (1)

0406-9959-03 30 CAPSULE in 1 BOTTLE (0406-9959-03)

Ingredients (1)

temazepam (22.5 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": "2794b069-e886-4191-9227-2b6c5e569b19", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0304069960016", "0304069962010", "0304069961013"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242", "198243", "485489"], "spl_set_id": ["c9bc61b4-a579-4003-98da-b6f6e381c150"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (0406-9959-03)", "package_ndc": "0406-9959-03", "marketing_start_date": "20100223"}], "brand_name": "TEMAZEPAM", "product_id": "0406-9959_2794b069-e886-4191-9227-2b6c5e569b19", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0406-9959", "dea_schedule": "CIV", "generic_name": "temazepam", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEMAZEPAM", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "22.5 mg/1"}], "application_number": "NDA018163", "marketing_category": "NDA", "marketing_start_date": "20100223", "listing_expiration_date": "20261231"}