temazepam

Generic: temazepam

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temazepam
Generic Name temazepam
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temazepam 15 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-380
Product ID 46708-380_387adad5-eb5e-429f-bc8a-b9ace387bc3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211542
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2018-11-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708380
Hyphenated Format 46708-380

Supplemental Identifiers

RxCUI
198241 198242 198243 485489
UPC
0346708379308 0346708382308 0346708380304 0346708381301
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 ANDA211542 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (46708-380-30)
  • 100 CAPSULE in 1 BOTTLE (46708-380-31)
  • 500 CAPSULE in 1 BOTTLE (46708-380-71)
  • 90 CAPSULE in 1 BOTTLE (46708-380-90)
source: ndc

Packages (4)

46708-380-30 30 CAPSULE in 1 BOTTLE (46708-380-30) 46708-380-31 100 CAPSULE in 1 BOTTLE (46708-380-31) 46708-380-71 500 CAPSULE in 1 BOTTLE (46708-380-71) 46708-380-90 90 CAPSULE in 1 BOTTLE (46708-380-90)

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": "387adad5-eb5e-429f-bc8a-b9ace387bc3f", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0346708379308", "0346708382308", "0346708380304", "0346708381301"], "unii": ["CHB1QD2QSS"], "rxcui": ["198241", "198242", "198243", "485489"], "spl_set_id": ["db839409-8e95-41d3-804e-dcd5d11f4934"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (46708-380-30)", "package_ndc": "46708-380-30", "marketing_start_date": "20181127"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (46708-380-31)", "package_ndc": "46708-380-31", "marketing_start_date": "20181127"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (46708-380-71)", "package_ndc": "46708-380-71", "marketing_start_date": "20181127"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (46708-380-90)", "package_ndc": "46708-380-90", "marketing_start_date": "20181127"}], "brand_name": "Temazepam", "product_id": "46708-380_387adad5-eb5e-429f-bc8a-b9ace387bc3f", "dosage_form": "CAPSULE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "46708-380", "dea_schedule": "CIV", "generic_name": "Temazepam", "labeler_name": "Alembic Pharmaceuticals Limited", "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": "20181127", "listing_expiration_date": "20261231"}