FDA.reportPublic FDA data

Doxycycline

Product NDC
21695-581
11-digit product format
216950581
Labeler code
21695
Product ID
21695-581_3f5f2d28-1053-44dd-8f9a-12bcc1172488
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA065095
Marketing category
ANDA
Marketing start
2003-07-02
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-581-142019-09-24C16284748780-1934fe258-47a0-48b1-e053-8cdaa90a720aDOXYCYCLINE HYCLATE, USP
21695-581-202019-09-24C16284748780-1934fe258-47a0-48b1-e053-8cdaa90a720aDOXYCYCLINE HYCLATE, USP
21695-581-302019-09-24C16284748780-1934fe258-47a0-48b1-e053-8cdaa90a720aDOXYCYCLINE HYCLATE, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-581-14Doxycycline14 in 1 BOTTLETABLET, COATED141
21695-581-20Doxycycline20 in 1 BOTTLETABLET, COATED201
21695-581-30Doxycycline30 in 1 BOTTLETABLET, COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-581-14EA - Each21695-581c7cb1a93-3aef-4224-ae0e-aef237725f6712012-07-24
21695-581-20EA - Each21695-581df90ff1c-50cb-41a7-9247-377437231ddc12012-07-24
21695-581-30EA - Each21695-581db881dfa-ace9-4723-b8cc-b89796472f5812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxycycline hyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
Doxycycline anhydrousACTIVE MOIETY334895S862DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-581DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 3 package rows20100217_091c71be-dd6c-4f7a-9af0-3222686345a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN091c71be-dd6c-4f7a-9af0-3222686345a51
1650143doxycycline hyclate 100 MG Oral TabletSCD091c71be-dd6c-4f7a-9af0-3222686345a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-581-142169505811414 in 1 BOTTLEHistorical
21695-581-202169505812020 in 1 BOTTLEHistorical
21695-581-302169505813030 in 1 BOTTLEHistorical