temazepam

Generic: temazepam

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 30 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-660
Product ID 55289-660_419b1d3a-0d95-2e95-e063-6294a90a2123
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071457
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1987-04-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55289660
Hyphenated Format 55289-660

Supplemental Identifiers

RxCUI
198242
UPC
0355289660828
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
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-01)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-30)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-60)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-82)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-90)
source: ndc

Packages (5)

55289-660-01 100 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-01) 55289-660-30 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-30) 55289-660-60 60 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-60) 55289-660-82 500 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-82) 55289-660-90 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-90)

Ingredients (1)

temazepam (30 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": "419b1d3a-0d95-2e95-e063-6294a90a2123", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0355289660828"], "unii": ["CHB1QD2QSS"], "rxcui": ["198242"], "spl_set_id": ["62379cd5-a314-43eb-a1ee-33997623bfa3"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-01)", "package_ndc": "55289-660-01", "marketing_start_date": "20160121"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-30)", "package_ndc": "55289-660-30", "marketing_start_date": "20160121"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-60)", "package_ndc": "55289-660-60", "marketing_start_date": "20160121"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-82)", "package_ndc": "55289-660-82", "marketing_start_date": "20200420"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-90)", "package_ndc": "55289-660-90", "marketing_start_date": "20160121"}], "brand_name": "temazepam", "product_id": "55289-660_419b1d3a-0d95-2e95-e063-6294a90a2123", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "55289-660", "dea_schedule": "CIV", "generic_name": "temazepam", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "temazepam", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "30 mg/1"}], "application_number": "ANDA071457", "marketing_category": "ANDA", "marketing_start_date": "19870421", "listing_expiration_date": "20261231"}