FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
12634-169
11-digit product format
126340169
Labeler code
12634
Product ID
12634-169_46dff4c0-9aad-20f9-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA062500
Marketing category
ANDA
Marketing start
1984-09-11
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
12634-169-002020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-012020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-092020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-122020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-182020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-402020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-422020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-452020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-502020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-522020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-542020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-572020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-592020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-602020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-612020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-632020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-662020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-672020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-692020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-712020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-742020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-782020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-792020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-802020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-812020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-822020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-842020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-852020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-902020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-912020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-922020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-932020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-942020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-952020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-962020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-972020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-982020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
12634-169-992020-01-31C16284748780-19d75b9d0-9d1e-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-169-00Doxycycline Hyclate10 in 1 BOTTLECAPSULE101
12634-169-01Doxycycline Hyclate100 in 1 BOTTLECAPSULE1001
12634-169-09Doxycycline Hyclate35 in 1 BOTTLECAPSULE351
12634-169-12Doxycycline Hyclate120 in 1 BOTTLECAPSULE1201
12634-169-18Doxycycline Hyclate180 in 1 BOTTLECAPSULE1801
12634-169-40Doxycycline Hyclate40 in 1 BOTTLECAPSULE401
12634-169-42Doxycycline Hyclate42 in 1 BOTTLECAPSULE421
12634-169-45Doxycycline Hyclate45 in 1 BOTTLECAPSULE451
12634-169-50Doxycycline Hyclate50 in 1 BOTTLECAPSULE501
12634-169-52Doxycycline Hyclate12 in 1 BLISTER PACKCAPSULE121
12634-169-54Doxycycline Hyclate14 in 1 BLISTER PACKCAPSULE141
12634-169-57Doxycycline Hyclate20 in 1 BLISTER PACKCAPSULE201
12634-169-59Doxycycline Hyclate30 in 1 BLISTER PACKCAPSULE301
12634-169-60Doxycycline Hyclate60 in 1 BOTTLECAPSULE601
12634-169-61Doxycycline Hyclate10 in 1 BLISTER PACKCAPSULE101
12634-169-63Doxycycline Hyclate3 in 1 BLISTER PACKCAPSULE31
12634-169-66Doxycycline Hyclate6 in 1 BLISTER PACKCAPSULE61
12634-169-67Doxycycline Hyclate7 in 1 BLISTER PACKCAPSULE71
12634-169-69Doxycycline Hyclate9 in 1 BLISTER PACKCAPSULE91
12634-169-71Doxycycline Hyclate30 in 1 BOTTLECAPSULE301
12634-169-74Doxycycline Hyclate24 in 1 BOTTLECAPSULE241
12634-169-78Doxycycline Hyclate28 in 1 BOTTLECAPSULE281
12634-169-79Doxycycline Hyclate25 in 1 BOTTLECAPSULE251
12634-169-80Doxycycline Hyclate20 in 1 BOTTLECAPSULE201
12634-169-81Doxycycline Hyclate21 in 1 BOTTLECAPSULE211
12634-169-82Doxycycline Hyclate12 in 1 BOTTLECAPSULE121
12634-169-84Doxycycline Hyclate14 in 1 BOTTLECAPSULE141
12634-169-85Doxycycline Hyclate15 in 1 BOTTLECAPSULE151
12634-169-90Doxycycline Hyclate90 in 1 BOTTLECAPSULE901
12634-169-91Doxycycline Hyclate1 in 1 BLISTER PACKCAPSULE11
12634-169-92Doxycycline Hyclate2 in 1 BOTTLECAPSULE21
12634-169-93Doxycycline Hyclate3 in 1 BOTTLECAPSULE31
12634-169-94Doxycycline Hyclate4 in 1 BOTTLECAPSULE41
12634-169-95Doxycycline Hyclate5 in 1 BOTTLECAPSULE51
12634-169-96Doxycycline Hyclate6 in 1 BOTTLECAPSULE61
12634-169-97Doxycycline Hyclate7 in 1 BOTTLECAPSULE71
12634-169-98Doxycycline Hyclate8 in 1 BOTTLECAPSULE81
12634-169-99Doxycycline Hyclate9 in 1 BOTTLECAPSULE91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-169DOXYCYCLINE HYCLATE CAPSULE [APOTHECA INC.]1Legacy NDC, 38 package rows20170125_46dff4c0-9aac-20f9-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN46dff4c0-9aac-20f9-e054-00144ff8d46c1
1649988doxycycline hyclate 100 MG Oral CapsuleSCD46dff4c0-9aac-20f9-e054-00144ff8d46c1
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY46dff4c0-9aac-20f9-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-169-001263401690010 in 1 BOTTLEHistorical
12634-169-0112634016901100 in 1 BOTTLEHistorical
12634-169-091263401690935 in 1 BOTTLEHistorical
12634-169-1212634016912120 in 1 BOTTLEHistorical
12634-169-1812634016918180 in 1 BOTTLEHistorical
12634-169-401263401694040 in 1 BOTTLEHistorical
12634-169-421263401694242 in 1 BOTTLEHistorical
12634-169-451263401694545 in 1 BOTTLEHistorical
12634-169-501263401695050 in 1 BOTTLEHistorical
12634-169-521263401695212 in 1 BLISTER PACKHistorical
12634-169-541263401695414 in 1 BLISTER PACKHistorical
12634-169-571263401695720 in 1 BLISTER PACKHistorical
12634-169-591263401695930 in 1 BLISTER PACKHistorical
12634-169-601263401696060 in 1 BOTTLEHistorical
12634-169-611263401696110 in 1 BLISTER PACKHistorical
12634-169-63126340169633 in 1 BLISTER PACKHistorical
12634-169-66126340169666 in 1 BLISTER PACKHistorical
12634-169-67126340169677 in 1 BLISTER PACKHistorical
12634-169-69126340169699 in 1 BLISTER PACKHistorical
12634-169-711263401697130 in 1 BOTTLEHistorical
12634-169-741263401697424 in 1 BOTTLEHistorical
12634-169-781263401697828 in 1 BOTTLEHistorical
12634-169-791263401697925 in 1 BOTTLEHistorical
12634-169-801263401698020 in 1 BOTTLEHistorical
12634-169-811263401698121 in 1 BOTTLEHistorical
12634-169-821263401698212 in 1 BOTTLEHistorical
12634-169-841263401698414 in 1 BOTTLEHistorical
12634-169-851263401698515 in 1 BOTTLEHistorical
12634-169-901263401699090 in 1 BOTTLEHistorical
12634-169-91126340169911 in 1 BLISTER PACKHistorical
12634-169-92126340169922 in 1 BOTTLEHistorical
12634-169-93126340169933 in 1 BOTTLEHistorical
12634-169-94126340169944 in 1 BOTTLEHistorical
12634-169-95126340169955 in 1 BOTTLEHistorical
12634-169-96126340169966 in 1 BOTTLEHistorical
12634-169-97126340169977 in 1 BOTTLEHistorical
12634-169-98126340169988 in 1 BOTTLEHistorical
12634-169-99126340169999 in 1 BOTTLEHistorical