trazodone hydrochloride

Generic: trazodone hydrochloride

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name trazodone hydrochloride
Generic Name trazodone hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

trazodone hydrochloride 300 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-808
Product ID 68382-808_24cb2e4c-a9ba-4283-8396-343f6aa03121
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205253
Listing Expiration 2027-12-31
Marketing Start 2017-12-11

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382808
Hyphenated Format 68382-808

Supplemental Identifiers

RxCUI
856364 856369 856373 856377
UPC
0368382808011
UNII
6E8ZO8LRNM

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 trazodone hydrochloride (source: ndc)
Generic Name trazodone hydrochloride (source: ndc)
Application Number ANDA205253 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-808-01)
  • 500 TABLET in 1 BOTTLE (68382-808-05)
  • 30 TABLET in 1 BOTTLE (68382-808-06)
  • 1000 TABLET in 1 BOTTLE (68382-808-10)
  • 90 TABLET in 1 BOTTLE (68382-808-16)
  • 10 BLISTER PACK in 1 CARTON (68382-808-77) / 10 TABLET in 1 BLISTER PACK (68382-808-30)
source: ndc

Packages (6)

68382-808-01 100 TABLET in 1 BOTTLE (68382-808-01) 68382-808-05 500 TABLET in 1 BOTTLE (68382-808-05) 68382-808-06 30 TABLET in 1 BOTTLE (68382-808-06) 68382-808-10 1000 TABLET in 1 BOTTLE (68382-808-10) 68382-808-16 90 TABLET in 1 BOTTLE (68382-808-16) 68382-808-77 10 BLISTER PACK in 1 CARTON (68382-808-77) / 10 TABLET in 1 BLISTER PACK (68382-808-30)

Ingredients (1)

trazodone hydrochloride (300 mg/1)

Linked Drug Pages (1)

Trazodone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "24cb2e4c-a9ba-4283-8396-343f6aa03121", "openfda": {"upc": ["0368382808011"], "unii": ["6E8ZO8LRNM"], "rxcui": ["856364", "856369", "856373", "856377"], "spl_set_id": ["704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-808-01)", "package_ndc": "68382-808-01", "marketing_start_date": "20171211"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-808-05)", "package_ndc": "68382-808-05", "marketing_start_date": "20171211"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-808-06)", "package_ndc": "68382-808-06", "marketing_start_date": "20171211"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-808-10)", "package_ndc": "68382-808-10", "marketing_start_date": "20171211"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-808-16)", "package_ndc": "68382-808-16", "marketing_start_date": "20171211"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-808-77)  / 10 TABLET in 1 BLISTER PACK (68382-808-30)", "package_ndc": "68382-808-77", "marketing_start_date": "20171211"}], "brand_name": "Trazodone Hydrochloride", "product_id": "68382-808_24cb2e4c-a9ba-4283-8396-343f6aa03121", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]"], "product_ndc": "68382-808", "generic_name": "Trazodone Hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trazodone Hydrochloride", "active_ingredients": [{"name": "TRAZODONE HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA205253", "marketing_category": "ANDA", "marketing_start_date": "20171211", "listing_expiration_date": "20271231"}