FDA.reportPublic FDA data

DOXYCYCLINE HYCLATE

Product NDC
70518-3869
11-digit product format
705183869
Labeler code
70518
Product ID
70518-3869_50733b85-067f-99c3-e063-6394a90a4244
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA211343
Marketing category
ANDA
Marketing start
2023-09-24
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
70518-3869-0DOXYCYCLINE HYCLATE20 in 1 BOTTLE, PLASTICTABLET2013
70518-3869-1DOXYCYCLINE HYCLATE10 in 1 BOTTLE, PLASTICTABLET1013
70518-3869-2DOXYCYCLINE HYCLATE14 in 1 BOTTLE, PLASTICTABLET1413
70518-3869-3DOXYCYCLINE HYCLATE90 in 1 BOTTLE, PLASTICTABLET9013
70518-3869-4DOXYCYCLINE HYCLATE60 in 1 BOTTLE, PLASTICTABLET6013
70518-3869-5DOXYCYCLINE HYCLATE100 in 1 BOTTLE, PLASTICTABLET10013
70518-3869-6DOXYCYCLINE HYCLATE28 in 1 BOTTLE, PLASTICTABLET2813
70518-3869-7DOXYCYCLINE HYCLATE50 in 1 BOTTLE, PLASTICTABLET5013
70518-3869-8DOXYCYCLINE HYCLATE56 in 1 BOTTLE, PLASTICTABLET5613
70518-3869-9DOXYCYCLINE HYCLATE30 in 1 BLISTER PACKTABLET3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3869DOXYCYCLINE HYCLATE TABLET [REMEDYREPACK INC.]6Current NDC, 10 package rows20250423_5fdc01c3-c62f-40cf-8351-91cbcc43d379.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN5fdc01c3-c62f-40cf-8351-91cbcc43d37913
1650143doxycycline hyclate 100 MG Oral TabletSCD5fdc01c3-c62f-40cf-8351-91cbcc43d37913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3869-07051838690020 TABLET in 1 BOTTLE, PLASTIC (70518-3869-0) 20 tablet2023-09-24NoNoHistorical
70518-3869-17051838690110 in 1 BOTTLE, PLASTICHistorical
70518-3869-27051838690214 TABLET in 1 BOTTLE, PLASTIC (70518-3869-2) 14 tablet2023-11-08NoNoHistorical
70518-3869-37051838690390 in 1 BOTTLE, PLASTICHistorical
70518-3869-47051838690460 TABLET in 1 BOTTLE, PLASTIC (70518-3869-4) 60 tablet2025-03-02NoNoHistorical
70518-3869-570518386905100 in 1 BOTTLE, PLASTICHistorical
70518-3869-67051838690628 TABLET in 1 BOTTLE, PLASTIC (70518-3869-6) 28 tablet2025-04-21NoNoHistorical
70518-3869-77051838690750 TABLET in 1 BOTTLE, PLASTIC (70518-3869-7) 50 tablet2025-07-14NoNoHistorical
70518-3869-87051838690856 TABLET in 1 BOTTLE, PLASTIC (70518-3869-8) 56 tablet2025-07-14NoNoHistorical
70518-3869-97051838690930 TABLET in 1 BLISTER PACK (70518-3869-9) 30 tablet2025-08-21NoNoHistorical