temazepam

Generic: temazepam

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 7.5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-004
Product ID 71610-004_a14e308f-61dd-47d4-bb0f-c69f9704c46b
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 71610004
Hyphenated Format 71610-004

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 NDA018163 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (71610-004-30)
  • 60 CAPSULE in 1 BOTTLE (71610-004-53)
  • 90 CAPSULE in 1 BOTTLE (71610-004-60)
source: ndc

Packages (3)

71610-004-30 30 CAPSULE in 1 BOTTLE (71610-004-30) 71610-004-53 60 CAPSULE in 1 BOTTLE (71610-004-53) 71610-004-60 90 CAPSULE in 1 BOTTLE (71610-004-60)

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": "a14e308f-61dd-47d4-bb0f-c69f9704c46b", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198243"], "spl_set_id": ["405b1ee2-777b-4fd3-b4ee-bd2aacbe1dc1"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-004-30)", "package_ndc": "71610-004-30", "marketing_start_date": "20170814"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-004-53)", "package_ndc": "71610-004-53", "marketing_start_date": "20171122"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-004-60)", "package_ndc": "71610-004-60", "marketing_start_date": "20171122"}], "brand_name": "TEMAZEPAM", "product_id": "71610-004_a14e308f-61dd-47d4-bb0f-c69f9704c46b", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-004", "dea_schedule": "CIV", "generic_name": "temazepam", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEMAZEPAM", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "7.5 mg/1"}], "application_number": "NDA018163", "marketing_category": "NDA", "marketing_start_date": "20100223", "listing_expiration_date": "20261231"}