temazepam

Generic: temazepam

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

Drug Facts

Product Profile

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

temazepam 15 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-2487
Product ID 70518-2487_4a2b6a93-5457-4e42-e063-6394a90a11e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071620
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2019-12-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705182487
Hyphenated Format 70518-2487

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 ANDA071620 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-2487-0) / 1 CAPSULE in 1 POUCH (70518-2487-1)
  • 30 CAPSULE in 1 BLISTER PACK (70518-2487-2)
source: ndc

Packages (2)

70518-2487-0 100 POUCH in 1 BOX (70518-2487-0) / 1 CAPSULE in 1 POUCH (70518-2487-1) 70518-2487-2 30 CAPSULE in 1 BLISTER PACK (70518-2487-2)

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": "4a2b6a93-5457-4e42-e063-6394a90a11e1", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241"], "spl_set_id": ["85919240-0bac-4ed9-97aa-f1aa29be7ffa"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-2487-0)  / 1 CAPSULE in 1 POUCH (70518-2487-1)", "package_ndc": "70518-2487-0", "marketing_start_date": "20191216"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-2487-2)", "package_ndc": "70518-2487-2", "marketing_start_date": "20250813"}], "brand_name": "Temazepam", "product_id": "70518-2487_4a2b6a93-5457-4e42-e063-6394a90a11e1", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "70518-2487", "dea_schedule": "CIV", "generic_name": "Temazepam", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temazepam", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "15 mg/1"}], "application_number": "ANDA071620", "marketing_category": "ANDA", "marketing_start_date": "20191216", "listing_expiration_date": "20271231"}