doxycycline hyclate

Generic: doxycycline hyclate

Labeler: solco healthcare us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxycycline hyclate
Generic Name doxycycline hyclate
Labeler solco healthcare us llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

doxycycline hyclate 200 mg/1

Manufacturer
Solco Healthcare US LLC

Identifiers & Regulatory

Product NDC 43547-325
Product ID 43547-325_49c9be01-a1bf-48aa-8ef4-0584e8dcaac5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207494
Listing Expiration 2027-12-31
Marketing Start 2016-11-28

Pharmacologic Class

Classes
tetracycline-class drug [epc] tetracyclines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547325
Hyphenated Format 43547-325

Supplemental Identifiers

RxCUI
799048 1423080 1653433
UPC
0343547325060 0343547324063 0343547462123
UNII
19XTS3T51U

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 doxycycline hyclate (source: ndc)
Generic Name doxycycline hyclate (source: ndc)
Application Number ANDA207494 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-325-06)
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-325-10)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-325-50)
source: ndc

Packages (3)

Ingredients (1)

doxycycline hyclate (200 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "49c9be01-a1bf-48aa-8ef4-0584e8dcaac5", "openfda": {"upc": ["0343547325060", "0343547324063", "0343547462123"], "unii": ["19XTS3T51U"], "rxcui": ["799048", "1423080", "1653433"], "spl_set_id": ["0a18d4c7-9484-4d3e-b61b-e81fe63fefec"], "manufacturer_name": ["Solco Healthcare US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-325-06)", "package_ndc": "43547-325-06", "marketing_start_date": "20161128"}, {"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-325-10)", "package_ndc": "43547-325-10", "marketing_start_date": "20161128"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-325-50)", "package_ndc": "43547-325-50", "marketing_start_date": "20161128"}], "brand_name": "DOXYCYCLINE HYCLATE", "product_id": "43547-325_49c9be01-a1bf-48aa-8ef4-0584e8dcaac5", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "43547-325", "generic_name": "DOXYCYCLINE HYCLATE", "labeler_name": "Solco Healthcare US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOXYCYCLINE HYCLATE", "active_ingredients": [{"name": "DOXYCYCLINE HYCLATE", "strength": "200 mg/1"}], "application_number": "ANDA207494", "marketing_category": "ANDA", "marketing_start_date": "20161128", "listing_expiration_date": "20271231"}