FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
70518-3213
11-digit product format
705183213
Labeler code
70518
Product ID
70518-3213_5217e493-243a-eb31-e063-6394a90a0a2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA062677
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3213-02023-03-21C16284748780-1f386c649-a6ba-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
70518-3213-02023-03-21C16284748780-1f386c649-a6ba-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
70518-3213-02023-03-21C16284748780-1f386c649-a6ba-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
70518-3213-02023-03-21C16284748780-1f386c649-a6ba-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
70518-3213-02023-01-30C16284748780-1f386c649-a6ba-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
70518-3213-02023-01-30C16284748780-1f386c649-a6ba-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
70518-3213-02023-01-30C16284748780-1f386c649-a6ba-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
70518-3213-02023-01-30C16284748780-1f386c649-a6ba-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3213-0Doxycycline Hyclate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1416
70518-3213-1Doxycycline Hyclate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1416
70518-3213-2Doxycycline Hyclate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6016
70518-3213-3Doxycycline Hyclate2 in 1 BOXTABLET, FILM COATED216
70518-3213-4Doxycycline Hyclate1 in 1 POUCHTABLET, FILM COATED116
70518-3213-5Doxycycline Hyclate20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2016
70518-3213-6Doxycycline Hyclate10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1016
70518-3213-7Doxycycline Hyclate20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2016
70518-3213-8Doxycycline Hyclate28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2816
70518-3213-9Doxycycline Hyclate56 in 1 BOTTLE, PLASTICTABLET, FILM COATED5616

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3213DOXYCYCLINE HYCLATE TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 10 package rows20250502_c8194d6e-c407-465e-a342-4d2d9756dfc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNc8194d6e-c407-465e-a342-4d2d9756dfc416
1650143doxycycline hyclate 100 MG Oral TabletSCDc8194d6e-c407-465e-a342-4d2d9756dfc416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3213-07051832130014 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-0) 2021-09-080000-00-00NoNoCurrent
70518-3213-17051832130114 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-1) 2023-06-25NoNoCurrent
70518-3213-27051832130260 in 1 BOTTLE, PLASTICHistorical
70518-3213-3705183213032 in 1 BOXHistorical
70518-3213-4705183213041 in 1 POUCHHistorical
70518-3213-57051832130520 in 1 BOTTLE, PLASTICHistorical
70518-3213-67051832130610 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-6) 2025-04-30NoNoCurrent
70518-3213-77051832130720 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-7) 2026-05-13NoNoCurrent
70518-3213-87051832130828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-8) 2026-05-13NoNoCurrent
70518-3213-97051832130956 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-9) 2026-05-13NoNoCurrent