FDA.reportPublic FDA data

Doxycycline

Product NDC
33261-143
11-digit product format
332610143
Labeler code
33261
Product ID
33261-143_d2bb7fc7-fb5c-4aee-b764-58cbe04933db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
No
Listing certified through
2019-12-31
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
33261-143-022020-01-31C16284748780-19d75b9d0-49e7-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
33261-143-072020-01-31C16284748780-19d75b9d0-49e7-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
33261-143-102020-01-31C16284748780-19d75b9d0-49e7-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
33261-143-142020-01-31C16284748780-19d75b9d0-49e7-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
33261-143-152020-01-31C16284748780-19d75b9d0-49e7-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
33261-143-202020-01-31C16284748780-19d75b9d0-49e7-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
33261-143-282020-01-31C16284748780-19d75b9d0-49e7-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
33261-143-302020-01-31C16284748780-19d75b9d0-49e7-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
33261-143-602020-01-31C16284748780-19d75b9d0-49e7-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
33261-143-902020-01-31C16284748780-19d75b9d0-49e7-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-143-02Doxycycline120 in 1 BOTTLE, PLASTICTABLET, COATED1202
33261-143-07Doxycycline7 in 1 BOTTLE, PLASTICTABLET, COATED72
33261-143-10Doxycycline10 in 1 BOTTLE, PLASTICTABLET, COATED102
33261-143-14Doxycycline14 in 1 BOTTLE, PLASTICTABLET, COATED142
33261-143-15Doxycycline15 in 1 BOTTLE, PLASTICTABLET, COATED152
33261-143-20Doxycycline20 in 1 BOTTLE, PLASTICTABLET, COATED202
33261-143-28Doxycycline28 in 1 BOTTLE, PLASTICTABLET, COATED282
33261-143-30Doxycycline30 in 1 BOTTLE, PLASTICTABLET, COATED302
33261-143-60Doxycycline60 in 1 BOTTLE, PLASTICTABLET, COATED602
33261-143-90Doxycycline90 in 1 BOTTLE, PLASTICTABLET, COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-143-07EA - Each33261-143efd757ff-14a2-4338-b562-4fb23deb241a12015-10-02
33261-143-10EA - Each33261-14305565ed2-adf9-4bca-acea-bef99f34b0ff12016-09-02
33261-143-14EA - Each33261-1435d04ab6b-9b6b-4682-b7c4-46d9fcb4108612015-10-02
33261-143-15EA - Each33261-143ad21a86c-0557-49e5-b612-26e41c18e72412016-09-02
33261-143-20EA - Each33261-143a02c6ae2-7e15-4c22-88b1-2408f1fa8eed12015-10-02
33261-143-28EA - Each33261-14369edd500-cb46-4b8f-8d1d-3e3c9acc349112015-10-02
33261-143-30EA - Each33261-1436f5a4c7b-8234-4469-9795-9727fa0a6f4f12015-10-02
33261-143-60EA - Each33261-1438caaceeb-32e4-4b71-afce-469ef30486de12015-10-02
33261-143-90EA - Each33261-143bb4dfadd-14cb-4ccc-89bc-8204d028497612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-143DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 10 package rows20140106_0bafbc2b-2713-402a-a3a7-4c66f2eea758.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN0bafbc2b-2713-402a-a3a7-4c66f2eea7582
1650143doxycycline hyclate 100 MG Oral TabletSCD0bafbc2b-2713-402a-a3a7-4c66f2eea7582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-143-0233261014302120 in 1 BOTTLE, PLASTICHistorical
33261-143-07332610143077 in 1 BOTTLE, PLASTICHistorical
33261-143-103326101431010 in 1 BOTTLE, PLASTICHistorical
33261-143-143326101431414 in 1 BOTTLE, PLASTICHistorical
33261-143-153326101431515 in 1 BOTTLE, PLASTICHistorical
33261-143-203326101432020 in 1 BOTTLE, PLASTICHistorical
33261-143-283326101432828 in 1 BOTTLE, PLASTICHistorical
33261-143-303326101433030 in 1 BOTTLE, PLASTICHistorical
33261-143-603326101436060 in 1 BOTTLE, PLASTICHistorical
33261-143-903326101439090 in 1 BOTTLE, PLASTICHistorical