temazepam

Generic: temazepam

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 15 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8493
Product ID 68788-8493_b38abef7-ba46-4b82-9712-9fe348e517d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211542
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888493
Hyphenated Format 68788-8493

Supplemental Identifiers

RxCUI
198241
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 ANDA211542 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (68788-8493-3)
source: ndc

Packages (1)

68788-8493-3 30 CAPSULE in 1 BOTTLE (68788-8493-3)

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": "b38abef7-ba46-4b82-9712-9fe348e517d2", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241"], "spl_set_id": ["cbe5bd6a-f36a-4557-82d8-ef4e49d310e9"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8493-3)", "package_ndc": "68788-8493-3", "marketing_start_date": "20230724"}], "brand_name": "Temazepam", "product_id": "68788-8493_b38abef7-ba46-4b82-9712-9fe348e517d2", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "68788-8493", "dea_schedule": "CIV", "generic_name": "Temazepam", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temazepam", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "15 mg/1"}], "application_number": "ANDA211542", "marketing_category": "ANDA", "marketing_start_date": "20230724", "listing_expiration_date": "20261231"}