temazepam

Generic: temazepam

Labeler: solco healthcare u.s., llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler solco healthcare u.s., llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 15 mg/1

Manufacturer
Solco Healthcare U.S., LLC

Identifiers & Regulatory

Product NDC 43547-612
Product ID 43547-612_5f04458d-b81c-47f8-ab06-3c47dffc5e4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201781
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-01-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547612
Hyphenated Format 43547-612

Supplemental Identifiers

RxCUI
198241 198242 198243 485489
UPC
0343547614102 0343547611101 0343547613037
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 ANDA201781 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (43547-612-10)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (43547-612-50)
source: ndc

Packages (2)

43547-612-10 100 CAPSULE in 1 BOTTLE, PLASTIC (43547-612-10) 43547-612-50 500 CAPSULE in 1 BOTTLE, PLASTIC (43547-612-50)

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": "5f04458d-b81c-47f8-ab06-3c47dffc5e4d", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0343547614102", "0343547611101", "0343547613037"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242", "198243", "485489"], "spl_set_id": ["3ce42f0e-821e-4c9a-8f6b-60621628fd4b"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Solco Healthcare U.S., LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (43547-612-10)", "package_ndc": "43547-612-10", "marketing_start_date": "20230105"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (43547-612-50)", "package_ndc": "43547-612-50", "marketing_start_date": "20230105"}], "brand_name": "Temazepam", "product_id": "43547-612_5f04458d-b81c-47f8-ab06-3c47dffc5e4d", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "43547-612", "dea_schedule": "CIV", "generic_name": "temazepam", "labeler_name": "Solco Healthcare U.S., LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temazepam", "active_ingredients": [{"name": "TEMAZEPAM", "strength": "15 mg/1"}], "application_number": "ANDA201781", "marketing_category": "ANDA", "marketing_start_date": "20230105", "listing_expiration_date": "20261231"}