Doxycycline Hyclate

Product NDC
66336-558
11-digit product format
663360558
Labeler code
66336
Product ID
66336-558_3ecd7b1f-5aef-41b8-8ab7-1897f87c347c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA062676
Marketing category
ANDA
Marketing start
1986-07-10
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
50 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
66336-558-302019-11-27C16284748780-19855d018-da3f-cd31-e053-dbdaa90ab51aDOXYCYCLINE 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
66336-558-30Doxycycline Hyclate30 in 1 BOTTLECAPSULE303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [DISPENSING SOLUTIONS, INC.]3
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [DISPENSING SOLUTIONS, INC.]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE CAPSULE [DISPENSING SOLUTIONS, INC.]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [DISPENSING SOLUTIONS, INC.]3
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE CAPSULE [DISPENSING SOLUTIONS, INC.]3
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHDOXYCYCLINE HYCLATE CAPSULE [DISPENSING SOLUTIONS, INC.]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [DISPENSING SOLUTIONS, INC.]3
gelatinINACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE CAPSULE [DISPENSING SOLUTIONS, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [DISPENSING SOLUTIONS, INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [DISPENSING SOLUTIONS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-558DOXYCYCLINE HYCLATE CAPSULE [DISPENSING SOLUTIONS, INC.]3Legacy NDC, 1 package rows20121004_ae36e3f4-d1cf-49b1-abed-f1e779900a23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649405doxycycline hyclate 50 MG Oral CapsulePSNae36e3f4-d1cf-49b1-abed-f1e779900a233
1649405doxycycline hyclate 50 MG Oral CapsuleSCDae36e3f4-d1cf-49b1-abed-f1e779900a233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-558-306633605583030 in 1 BOTTLEHistorical