doxycycline hyclate

Generic: doxycycline hyclate

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxycycline hyclate
Generic Name doxycycline hyclate
Labeler epic pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

doxycycline hyclate 100 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-310
Product ID 42806-310_108c5769-3b01-40dd-b493-1f38df313b4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062269
Listing Expiration 2026-12-31
Marketing Start 2025-03-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806310
Hyphenated Format 42806-310

Supplemental Identifiers

RxCUI
1650143
UPC
0342806310502
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 ANDA062269 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42806-310-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (42806-310-05)
  • 50 TABLET, FILM COATED in 1 BOTTLE (42806-310-50)
source: ndc

Packages (3)

Ingredients (1)

doxycycline hyclate (100 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "108c5769-3b01-40dd-b493-1f38df313b4c", "openfda": {"upc": ["0342806310502"], "unii": ["19XTS3T51U"], "rxcui": ["1650143"], "spl_set_id": ["2b402587-8ecc-4fea-83ad-8071345b6356"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42806-310-01)", "package_ndc": "42806-310-01", "marketing_start_date": "20250307"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42806-310-05)", "package_ndc": "42806-310-05", "marketing_start_date": "20250307"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (42806-310-50)", "package_ndc": "42806-310-50", "marketing_start_date": "20250307"}], "brand_name": "Doxycycline Hyclate", "product_id": "42806-310_108c5769-3b01-40dd-b493-1f38df313b4c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "42806-310", "generic_name": "Doxycycline Hyclate", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxycycline Hyclate", "active_ingredients": [{"name": "DOXYCYCLINE HYCLATE", "strength": "100 mg/1"}], "application_number": "ANDA062269", "marketing_category": "ANDA", "marketing_start_date": "20250307", "listing_expiration_date": "20261231"}