temazepam

Generic: temazepam

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA 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 43353-152
Product ID 43353-152_7e272f5a-86d5-48f5-92b5-50bc33f351b3
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 43353152
Hyphenated Format 43353-152

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 CAPSULE in 1 BOTTLE (43353-152-30)
  • 60 CAPSULE in 1 BOTTLE (43353-152-53)
  • 90 CAPSULE in 1 BOTTLE (43353-152-60)
source: ndc

Packages (3)

43353-152-30 30 CAPSULE in 1 BOTTLE (43353-152-30) 43353-152-53 60 CAPSULE in 1 BOTTLE (43353-152-53) 43353-152-60 90 CAPSULE in 1 BOTTLE (43353-152-60)

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": "7e272f5a-86d5-48f5-92b5-50bc33f351b3", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198243"], "spl_set_id": ["d4a241c7-a4de-4f6b-b831-e063cf8c3d54"], "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 (43353-152-30)", "package_ndc": "43353-152-30", "marketing_start_date": "20160222"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (43353-152-53)", "package_ndc": "43353-152-53", "marketing_start_date": "20160429"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (43353-152-60)", "package_ndc": "43353-152-60", "marketing_start_date": "20160216"}], "brand_name": "Temazepam", "product_id": "43353-152_7e272f5a-86d5-48f5-92b5-50bc33f351b3", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "43353-152", "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": "ANDA071457", "marketing_category": "ANDA", "marketing_start_date": "20150325", "listing_expiration_date": "20261231"}