doxycycline monohydrate

Generic: doxycycline monohydrate

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxycycline monohydrate
Generic Name doxycycline monohydrate
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

doxycycline 100 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0319
Product ID 80425-0319_2a9bf7d3-46da-0dfa-e063-6394a90a76a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209582
Listing Expiration 2026-12-31
Marketing Start 2023-04-11

Pharmacologic Class

Established (EPC)
tetracycline-class drug [epc]
Chemical Structure
tetracyclines [chemical/ingredient]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250319
Hyphenated Format 80425-0319

Supplemental Identifiers

RxCUI
1650142
UNII
N12000U13O
NUI
N0000175882 N0000007948

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 monohydrate (source: ndc)
Generic Name doxycycline monohydrate (source: ndc)
Application Number ANDA209582 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0319-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0319-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0319-3)
source: ndc

Packages (3)

80425-0319-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0319-1) 80425-0319-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0319-2) 80425-0319-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0319-3)

Ingredients (1)

doxycycline (100 mg/1)

Linked Drug Pages (1)

Doxycycline Monohydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a9bf7d3-46da-0dfa-e063-6394a90a76a4", "openfda": {"nui": ["N0000175882", "N0000007948"], "unii": ["N12000U13O"], "rxcui": ["1650142"], "spl_set_id": ["f91373f2-c57b-f1f1-e053-6294a90a7bdd"], "pharm_class_cs": ["Tetracyclines [Chemical/Ingredient]"], "pharm_class_epc": ["Tetracycline-class Drug [EPC]"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0319-1)", "package_ndc": "80425-0319-1", "marketing_start_date": "20230411"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0319-2)", "package_ndc": "80425-0319-2", "marketing_start_date": "20230411"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0319-3)", "package_ndc": "80425-0319-3", "marketing_start_date": "20230411"}], "brand_name": "Doxycycline Monohydrate", "product_id": "80425-0319_2a9bf7d3-46da-0dfa-e063-6394a90a76a4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "80425-0319", "generic_name": "Doxycycline Monohydrate", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxycycline Monohydrate", "active_ingredients": [{"name": "DOXYCYCLINE", "strength": "100 mg/1"}], "application_number": "ANDA209582", "marketing_category": "ANDA", "marketing_start_date": "20230411", "listing_expiration_date": "20261231"}