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 15 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-196
Product ID 55289-196_4199da42-51af-009d-e063-6394a90a906c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071456
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 55289196
Hyphenated Format 55289-196

Supplemental Identifiers

RxCUI
198241
UPC
0355289196822
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 ANDA071456 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-01)
  • 14 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-14)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-30)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-60)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-82)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-90)
source: ndc

Packages (6)

55289-196-01 100 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-01) 55289-196-14 14 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-14) 55289-196-30 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-30) 55289-196-60 60 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-60) 55289-196-82 500 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-82) 55289-196-90 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-90)

Ingredients (1)

temazepam (15 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": "4199da42-51af-009d-e063-6394a90a906c", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0355289196822"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241"], "spl_set_id": ["45ef5e9c-f381-48d3-895d-e1d29be856ac"], "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 (55289-196-01)", "package_ndc": "55289-196-01", "marketing_start_date": "20160205"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-14)", "package_ndc": "55289-196-14", "marketing_start_date": "20160205"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-30)", "package_ndc": "55289-196-30", "marketing_start_date": "20160205"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-60)", "package_ndc": "55289-196-60", "marketing_start_date": "20160205"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-82)", "package_ndc": "55289-196-82", "marketing_start_date": "20200420"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-90)", "package_ndc": "55289-196-90", "marketing_start_date": "20181213"}], "brand_name": "temazepam", "product_id": "55289-196_4199da42-51af-009d-e063-6394a90a906c", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "55289-196", "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": "15 mg/1"}], "application_number": "ANDA071456", "marketing_category": "ANDA", "marketing_start_date": "19870421", "listing_expiration_date": "20261231"}