doxycycline hyclate

Generic: doxycycline hyclate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxycycline hyclate
Generic Name doxycycline hyclate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

doxycycline hyclate 20 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 53489-647
Product ID 53489-647_31dd6775-5a9a-9e21-e063-6294a90aa546
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065134
Listing Expiration 2026-12-31
Marketing Start 2005-05-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53489647
Hyphenated Format 53489-647

Supplemental Identifiers

RxCUI
283535
UPC
0353489647014
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 ANDA065134 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-01)
  • 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-06)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-07)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-90)
source: ndc

Packages (7)

53489-647-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-01) 53489-647-03 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-03) 53489-647-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-05) 53489-647-06 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-06) 53489-647-07 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-07) 53489-647-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-10) 53489-647-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-90)

Ingredients (1)

doxycycline hyclate (20 mg/1)

Linked Drug Pages (1)

Doxycycline Hyclate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "31dd6775-5a9a-9e21-e063-6294a90aa546", "openfda": {"upc": ["0353489647014"], "unii": ["19XTS3T51U"], "rxcui": ["283535"], "spl_set_id": ["bff3f426-44fc-4dbf-96df-df44011103e8"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-01)", "package_ndc": "53489-647-01", "marketing_start_date": "20050513"}, {"sample": false, "description": "250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-03)", "package_ndc": "53489-647-03", "marketing_start_date": "20050513"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-05)", "package_ndc": "53489-647-05", "marketing_start_date": "20050513"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-06)", "package_ndc": "53489-647-06", "marketing_start_date": "20050513"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-07)", "package_ndc": "53489-647-07", "marketing_start_date": "20050513"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-10)", "package_ndc": "53489-647-10", "marketing_start_date": "20050513"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-90)", "package_ndc": "53489-647-90", "marketing_start_date": "20050513"}], "brand_name": "Doxycycline Hyclate", "product_id": "53489-647_31dd6775-5a9a-9e21-e063-6294a90aa546", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "53489-647", "generic_name": "Doxycycline Hyclate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxycycline Hyclate", "active_ingredients": [{"name": "DOXYCYCLINE HYCLATE", "strength": "20 mg/1"}], "application_number": "ANDA065134", "marketing_category": "ANDA", "marketing_start_date": "20050513", "listing_expiration_date": "20261231"}