FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
33261-151
11-digit product format
332610151
Labeler code
33261
Product ID
33261-151_72aa6c88-0bac-469c-a1d8-4433c4f926b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA062396
Marketing category
ANDA
Marketing start
1984-05-07
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
2018-12-31
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
33261-151-022020-01-31C16284748780-19d75b9d1-0ae6-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE CAPSULES, USP
33261-151-102020-01-31C16284748780-19d75b9d1-0ae6-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE CAPSULES, USP
33261-151-142020-01-31C16284748780-19d75b9d1-0ae6-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE CAPSULES, USP
33261-151-202020-01-31C16284748780-19d75b9d1-0ae6-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE CAPSULES, USP
33261-151-262020-01-31C16284748780-19d75b9d1-0ae6-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE CAPSULES, USP
33261-151-302020-01-31C16284748780-19d75b9d1-0ae6-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE CAPSULES, USP
33261-151-602020-01-31C16284748780-19d75b9d1-0ae6-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE CAPSULES, USP
33261-151-902020-01-31C16284748780-19d75b9d1-0ae6-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-151-02Doxycycline Hyclate120 in 1 BOTTLE, PLASTICCAPSULE1201
33261-151-10Doxycycline Hyclate10 in 1 BOTTLE, PLASTICCAPSULE101
33261-151-14Doxycycline Hyclate14 in 1 BOTTLE, PLASTICCAPSULE141
33261-151-20Doxycycline Hyclate20 in 1 BOTTLE, PLASTICCAPSULE201
33261-151-26Doxycycline Hyclate26 in 1 BOX, UNIT-DOSECAPSULE261
33261-151-30Doxycycline Hyclate30 in 1 BOTTLE, PLASTICCAPSULE301
33261-151-60Doxycycline Hyclate60 in 1 BOTTLE, PLASTICCAPSULE601
33261-151-90Doxycycline Hyclate90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-151-02EA - Each33261-1518f64cb2d-56b8-429a-b5a5-cc199afdcc2912015-10-02
33261-151-14EA - Each33261-151dba38951-177d-4540-9824-1dd9be966bc512015-10-02
33261-151-20EA - Each33261-151ada1e22c-b2bd-4eb7-b739-c9f5ee1a3ffd12015-10-02
33261-151-30EA - Each33261-1510f9128be-c965-4330-9511-5b327600caab12015-10-02
33261-151-60EA - Each33261-151d7491d80-124e-488d-85a7-c2c0b2c2227212015-10-02
33261-151-90EA - Each33261-15124077226-8f4f-4b8e-9d01-27c66efd2df712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-151DOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 8 package rows20120922_83cd3589-f0ec-43e3-93a8-4a69dc235244.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN83cd3589-f0ec-43e3-93a8-4a69dc2352441
1649988doxycycline hyclate 100 MG Oral CapsuleSCD83cd3589-f0ec-43e3-93a8-4a69dc2352441
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY83cd3589-f0ec-43e3-93a8-4a69dc2352441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-151-0233261015102120 in 1 BOTTLE, PLASTICHistorical
33261-151-103326101511010 in 1 BOTTLE, PLASTICHistorical
33261-151-143326101511414 in 1 BOTTLE, PLASTICHistorical
33261-151-203326101512020 in 1 BOTTLE, PLASTICHistorical
33261-151-263326101512626 in 1 BOX, UNIT-DOSEHistorical
33261-151-303326101513030 in 1 BOTTLE, PLASTICHistorical
33261-151-603326101516060 in 1 BOTTLE, PLASTICHistorical
33261-151-903326101519090 in 1 BOTTLE, PLASTICHistorical