FDA.reportPublic FDA data

DOXYCYCLINE HYCLATE

Product NDC
61919-082
11-digit product format
619190082
Labeler code
61919
Product ID
61919-082_4c47f8bd-4a1e-dd8f-e063-6294a90a29d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA062676
Marketing category
ANDA
Marketing start
2014-01-01
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOXYCYCLINE HYCLATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1649988

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
61919-082-202025-01-30C16284748780-12cef2736-6501-d83d-e063-dadaa90ab31fDOXYCYCLINE HYCLATE
61919-082-602025-01-30C16284748780-12cef2736-6501-d83d-e063-dadaa90ab31fDOXYCYCLINE HYCLATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-082-20DOXYCYCLINE HYCLATE20 in 1 BOTTLECAPSULE2010
61919-082-30DOXYCYCLINE HYCLATE30 in 1 BOTTLECAPSULE3010
61919-082-60DOXYCYCLINE HYCLATE60 in 1 BOTTLECAPSULE6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-082-20EA - Each61919-0824d45eee7-6d85-43ee-b273-c573cc24b75612015-04-03
61919-082-30EA - Each61919-082734600f1-41db-49d6-9e4b-106a73420fbe12026-05-22

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-082DOXYCYCLINE HYCLATE CAPSULE [DIRECT RX]9Current NDC, Legacy NDC, 3 package rows20221012_9798c4de-8af7-41c4-acc2-1e9775194297.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN9798c4de-8af7-41c4-acc2-1e977519429710
1649988doxycycline hyclate 100 MG Oral CapsuleSCD9798c4de-8af7-41c4-acc2-1e977519429710
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY9798c4de-8af7-41c4-acc2-1e977519429710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-082-206191900822020 CAPSULE in 1 BOTTLE (61919-082-20) 20 capsule2015-01-010000-00-00NoNoCurrent
61919-082-306191900823030 CAPSULE in 1 BOTTLE (61919-082-30) 30 capsule2014-01-01NoNoCurrent
61919-082-606191900826060 CAPSULE in 1 BOTTLE (61919-082-60) 60 capsule2015-01-010000-00-00NoNoCurrent