Doxycycline Hyclate

Product NDC
50268-277
11-digit product format
502680277
Labeler code
50268
Product ID
50268-277_461626eb-97e0-bb4c-e063-6394a90a10c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA062676
Marketing category
ANDA
Marketing start
2014-06-04
Substance
DOXYCYCLINE HYCLATE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1649405, 1649988, 1650143

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-277-11Doxycycline Hyclate1 in 1 BLISTER PACKCAPSULE18
50268-277-15Doxycycline Hyclate50 in 1 BOXCAPSULE508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-277-11EA - Each50268-277d5a1d361-463c-4275-8046-45f0e6359c5d12015-05-05
50268-277-15EA - Each50268-27781b6c520-83ac-444a-b62b-9bf4f284aab712014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
gelatinINACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-277DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [AVPAK]7Current NDC, Legacy NDC, 2 package rows20240110_53ff9f7e-0db0-c841-d334-4cf31f658828.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN53ff9f7e-0db0-c841-d334-4cf31f6588288
1650143doxycycline hyclate 100 MG Oral TabletPSN53ff9f7e-0db0-c841-d334-4cf31f6588288
1649405doxycycline hyclate 50 MG Oral CapsulePSN53ff9f7e-0db0-c841-d334-4cf31f6588288
1649988doxycycline hyclate 100 MG Oral CapsuleSCD53ff9f7e-0db0-c841-d334-4cf31f6588288
1650143doxycycline hyclate 100 MG Oral TabletSCD53ff9f7e-0db0-c841-d334-4cf31f6588288
1649405doxycycline hyclate 50 MG Oral CapsuleSCD53ff9f7e-0db0-c841-d334-4cf31f6588288
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY53ff9f7e-0db0-c841-d334-4cf31f6588288

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-277-11502680277111 in 1 BLISTER PACKHistorical
50268-277-155026802771550 BLISTER PACK in 1 BOX (50268-277-15) / 1 CAPSULE in 1 BLISTER PACK (50268-277-11) 50 blister pack2014-06-040000-00-00NoNoCurrent