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 CAPSULE
Routes
ORAL
Active Ingredients

doxycycline hyclate 50 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 53489-118
Product ID 53489-118_3309ec4b-fda9-8b52-e063-6394a90a5e18
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062676
Listing Expiration 2026-12-31
Marketing Start 1986-07-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53489118
Hyphenated Format 53489-118

Supplemental Identifiers

RxCUI
1649405 1649988 1650143
UPC
0353489118026
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 ANDA062676 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 50 CAPSULE in 1 BOTTLE, PLASTIC (53489-118-02)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (53489-118-05)
source: ndc

Packages (2)

53489-118-02 50 CAPSULE in 1 BOTTLE, PLASTIC (53489-118-02) 53489-118-05 500 CAPSULE in 1 BOTTLE, PLASTIC (53489-118-05)

Ingredients (1)

doxycycline hyclate (50 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": "3309ec4b-fda9-8b52-e063-6394a90a5e18", "openfda": {"upc": ["0353489118026"], "unii": ["19XTS3T51U"], "rxcui": ["1649405", "1649988", "1650143"], "spl_set_id": ["214a9cfe-a522-4022-81d4-e59f447401fe"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CAPSULE in 1 BOTTLE, PLASTIC (53489-118-02)", "package_ndc": "53489-118-02", "marketing_start_date": "19860710"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (53489-118-05)", "package_ndc": "53489-118-05", "marketing_start_date": "19860710"}], "brand_name": "Doxycycline Hyclate", "product_id": "53489-118_3309ec4b-fda9-8b52-e063-6394a90a5e18", "dosage_form": "CAPSULE", "pharm_class": ["Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "53489-118", "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": "50 mg/1"}], "application_number": "ANDA062676", "marketing_category": "ANDA", "marketing_start_date": "19860710", "listing_expiration_date": "20261231"}