FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
70518-3214
11-digit product format
705183214
Labeler code
70518
Product ID
70518-3214_4ecf4677-2424-6125-e063-6294a90afa47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA062269
Marketing category
ANDA
Marketing start
2021-09-08
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 Hyclate
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
70518-3214-0Doxycycline Hyclate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1411
70518-3214-1Doxycycline Hyclate20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2011
70518-3214-2Doxycycline Hyclate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1411
70518-3214-3Doxycycline Hyclate2 in 1 BOXTABLET, FILM COATED211
70518-3214-4Doxycycline Hyclate1 in 1 POUCHTABLET, FILM COATED111
70518-3214-5Doxycycline Hyclate10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3214DOXYCYCLINE HYCLATE TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 6 package rows20250206_2305ab4a-7d08-41f6-9c39-c9b6835be389.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN2305ab4a-7d08-41f6-9c39-c9b6835be38911
1650143doxycycline hyclate 100 MG Oral TabletSCD2305ab4a-7d08-41f6-9c39-c9b6835be38911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3214-07051832140014 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3214-0) 2021-09-080000-00-00NoNoCurrent
70518-3214-17051832140120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3214-1) 2022-03-300000-00-00NoNoCurrent
70518-3214-27051832140214 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3214-2) 2022-07-260000-00-00NoNoCurrent
70518-3214-3705183214032 in 1 BOXHistorical
70518-3214-4705183214041 in 1 POUCHHistorical
70518-3214-57051832140510 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3214-5) 2025-01-30NoNoHistorical