temazepam

Generic: temazepam

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 30 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-557
Product ID 53746-557_18d70b19-ff94-443e-8169-cb7e87895146
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203482
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-02-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746557
Hyphenated Format 53746-557

Supplemental Identifiers

RxCUI
198241 198242
UPC
0353746557018 0353746556011
UNII
CHB1QD2QSS
NUI
N0000175694 M0002356

Packaging Origin

Original Packager
true

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 ANDA203482 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (53746-557-01)
  • 500 CAPSULE in 1 BOTTLE (53746-557-05)
source: ndc

Packages (2)

53746-557-01 100 CAPSULE in 1 BOTTLE (53746-557-01) 53746-557-05 500 CAPSULE in 1 BOTTLE (53746-557-05)

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": "18d70b19-ff94-443e-8169-cb7e87895146", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0353746557018", "0353746556011"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242"], "spl_set_id": ["6248295e-8176-48f8-8e9d-bba6deacaf0d"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (53746-557-01)", "package_ndc": "53746-557-01", "marketing_start_date": "20240219"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (53746-557-05)", "package_ndc": "53746-557-05", "marketing_start_date": "20240219"}], "brand_name": "Temazepam", "product_id": "53746-557_18d70b19-ff94-443e-8169-cb7e87895146", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "53746-557", "dea_schedule": "CIV", "generic_name": "Temazepam", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temazepam", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "30 mg/1"}], "application_number": "ANDA203482", "marketing_category": "ANDA", "marketing_start_date": "20240219", "listing_expiration_date": "20261231"}