temazepam

Generic: temazepam

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA 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 72789-449
Product ID 72789-449_4124bd2d-cd9e-a9dc-e063-6294a90a25d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018163
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2010-02-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789449
Hyphenated Format 72789-449

Supplemental Identifiers

RxCUI
198242
UPC
0372789449302
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 NDA018163 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-449-30)
source: ndc

Packages (1)

72789-449-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-449-30)

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": "4124bd2d-cd9e-a9dc-e063-6294a90a25d1", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0372789449302"], "unii": ["CHB1QD2QSS"], "rxcui": ["198242"], "spl_set_id": ["97afda58-4daf-4192-bd87-3ccbb000ee52"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-449-30)", "package_ndc": "72789-449-30", "marketing_start_date": "20241106"}], "brand_name": "TEMAZEPAM", "product_id": "72789-449_4124bd2d-cd9e-a9dc-e063-6294a90a25d1", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "72789-449", "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": "NDA018163", "marketing_category": "NDA", "marketing_start_date": "20100223", "listing_expiration_date": "20261231"}