Doxycycline Monohydrate

Product NDC
80425-0319
11-digit product format
804250319
Labeler code
80425
Product ID
80425-0319_2a9bf7d3-46da-0dfa-e063-6394a90a76a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Monohydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA209582
Marketing category
ANDA
Marketing start
2023-04-11
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
N12000U13ODOXYCYCLINE17086-28-1DOXYCYCLINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0319-18042503190130 TABLET, FILM COATED in 1 BOTTLE (80425-0319-1) 2023-04-11NoNoHistorical
80425-0319-28042503190260 TABLET, FILM COATED in 1 BOTTLE (80425-0319-2) 2023-04-11NoNoHistorical
80425-0319-38042503190390 TABLET, FILM COATED in 1 BOTTLE (80425-0319-3) 2023-04-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxycycline Monohydrate TabletsAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL2