temazepam

Generic: temazepam

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler ascend laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 7.5 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-148
Product ID 67877-148_45d37c04-846d-4f50-ac42-52b2d051d115
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071457
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2012-06-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877148
Hyphenated Format 67877-148

Supplemental Identifiers

RxCUI
198241 198242 198243 485489
UPC
0367877147017 0367877146010 0367877148014 0367877149011
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 ANDA071457 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (67877-148-01)
  • 500 CAPSULE in 1 BOTTLE (67877-148-05)
  • 30 CAPSULE in 1 BOTTLE (67877-148-30)
source: ndc

Packages (3)

67877-148-01 100 CAPSULE in 1 BOTTLE (67877-148-01) 67877-148-05 500 CAPSULE in 1 BOTTLE (67877-148-05) 67877-148-30 30 CAPSULE in 1 BOTTLE (67877-148-30)

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": "45d37c04-846d-4f50-ac42-52b2d051d115", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0367877147017", "0367877146010", "0367877148014", "0367877149011"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242", "198243", "485489"], "spl_set_id": ["8f54731f-c5b7-492c-acb0-444c5fbb7029"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (67877-148-01)", "package_ndc": "67877-148-01", "marketing_start_date": "20120628"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (67877-148-05)", "package_ndc": "67877-148-05", "marketing_start_date": "20120628"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (67877-148-30)", "package_ndc": "67877-148-30", "marketing_start_date": "20120628"}], "brand_name": "temazepam", "product_id": "67877-148_45d37c04-846d-4f50-ac42-52b2d051d115", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "67877-148", "dea_schedule": "CIV", "generic_name": "temazepam", "labeler_name": "Ascend Laboratories, 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": "20120628", "listing_expiration_date": "20261231"}