FDA.reportPublic FDA data

Doxycycline

Product NDC
70518-3039
11-digit product format
705183039
Labeler code
70518
Product ID
70518-3039_4b079de0-dc33-87e7-e063-6294a90a468d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065095
Marketing category
ANDA
Marketing start
2021-03-04
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1650143

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3039-0Doxycycline14 in 1 BOTTLE, PLASTICTABLET, COATED1415
70518-3039-1Doxycycline14 in 1 BOTTLE, PLASTICTABLET, COATED1415
70518-3039-2Doxycycline60 in 1 BOTTLE, PLASTICTABLET, COATED6015
70518-3039-3Doxycycline2 in 1 BOXTABLET, COATED215
70518-3039-4Doxycycline1 in 1 POUCHTABLET, COATED115
70518-3039-5Doxycycline2 in 1 BOTTLE, PLASTICTABLET, COATED215
70518-3039-6Doxycycline20 in 1 BOTTLE, PLASTICTABLET, COATED2015
70518-3039-7Doxycycline20 in 1 BOTTLE, PLASTICTABLET, COATED2015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3039DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 8 package rows20241122_db53637e-16ac-41b0-b9d5-553471405d64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNdb53637e-16ac-41b0-b9d5-553471405d6415
1650143doxycycline hyclate 100 MG Oral TabletSCDdb53637e-16ac-41b0-b9d5-553471405d6415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3039-07051830390014 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3039-0) 2021-03-040000-00-00NoNoCurrent
70518-3039-17051830390114 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3039-1) 2021-05-130000-00-00NoNoCurrent
70518-3039-27051830390260 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3039-2) 2023-06-25NoNoHistorical
70518-3039-3705183039032 in 1 BOXHistorical
70518-3039-4705183039041 in 1 POUCHHistorical
70518-3039-5705183039052 in 1 BOTTLE, PLASTICHistorical
70518-3039-67051830390620 in 1 BOTTLE, PLASTICHistorical
70518-3039-77051830390720 in 1 BOTTLE, PLASTICHistorical