FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
52959-055
11-digit product format
529590055
Labeler code
52959
Product ID
52959-055_7f84a5cf-17aa-4078-ba9c-89dfb8ea349b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA062396
Marketing category
ANDA
Marketing start
1984-11-07
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
52959-055-002020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate
52959-055-022020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate
52959-055-062020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate
52959-055-072020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate
52959-055-102020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate
52959-055-122020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate
52959-055-142020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate
52959-055-152020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate
52959-055-202020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate
52959-055-282020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate
52959-055-302020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate
52959-055-902020-01-31C16284748780-19d75b9d1-0816-f424-e053-dadaa90a57ceDoxycycline Hyclate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-055-00Doxycycline Hyclate100 in 1 BOTTLE, PLASTICCAPSULE1003
52959-055-02Doxycycline Hyclate120 in 1 BOTTLE, PLASTICCAPSULE1203
52959-055-06Doxycycline Hyclate6 in 1 BOTTLE, PLASTICCAPSULE63
52959-055-07Doxycycline Hyclate7 in 1 BOTTLE, PLASTICCAPSULE73
52959-055-10Doxycycline Hyclate10 in 1 BOTTLE, PLASTICCAPSULE103
52959-055-12Doxycycline Hyclate12 in 1 BOTTLE, PLASTICCAPSULE123
52959-055-14Doxycycline Hyclate14 in 1 BOTTLE, PLASTICCAPSULE143
52959-055-15Doxycycline Hyclate15 in 1 BOTTLE, PLASTICCAPSULE153
52959-055-20Doxycycline Hyclate20 in 1 BOTTLE, PLASTICCAPSULE203
52959-055-28Doxycycline Hyclate28 in 1 BOTTLE, PLASTICCAPSULE283
52959-055-30Doxycycline Hyclate30 in 1 BOTTLE, PLASTICCAPSULE303
52959-055-90Doxycycline Hyclate90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-055DOXYCYCLINE HYCLATE CAPSULE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 12 package rows20111216_4d0ba36c-0a4a-4faf-9f1d-79e5273808d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN4d0ba36c-0a4a-4faf-9f1d-79e5273808d53
1649988doxycycline hyclate 100 MG Oral CapsuleSCD4d0ba36c-0a4a-4faf-9f1d-79e5273808d53
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY4d0ba36c-0a4a-4faf-9f1d-79e5273808d53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-055-0052959005500100 in 1 BOTTLE, PLASTICHistorical
52959-055-0252959005502120 in 1 BOTTLE, PLASTICHistorical
52959-055-06529590055066 in 1 BOTTLE, PLASTICHistorical
52959-055-07529590055077 in 1 BOTTLE, PLASTICHistorical
52959-055-105295900551010 in 1 BOTTLE, PLASTICHistorical
52959-055-125295900551212 in 1 BOTTLE, PLASTICHistorical
52959-055-145295900551414 in 1 BOTTLE, PLASTICHistorical
52959-055-155295900551515 in 1 BOTTLE, PLASTICHistorical
52959-055-205295900552020 in 1 BOTTLE, PLASTICHistorical
52959-055-285295900552828 in 1 BOTTLE, PLASTICHistorical
52959-055-305295900553030 in 1 BOTTLE, PLASTICHistorical
52959-055-905295900559090 in 1 BOTTLE, PLASTICHistorical