Doxycycline

Product NDC
63304-173
11-digit product format
633040173
Labeler code
63304
Product ID
63304-173_fd417a50-69b5-40b4-89fd-58aea77ab547
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries Inc.
Application
ANDA065356
Marketing category
ANDA
Marketing start
2018-08-06
Substance
DOXYCYCLINE
Active strength
150 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN12000U13O
Rxcui1649429, 1650142, 1650444, 1652673

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
63304-173-03Doxycycline10 in 1 BOTTLETABLET, FILM COATED105
63304-173-10Doxycycline1000 in 1 BOTTLETABLET, FILM COATED10005
63304-173-11Doxycycline10 in 1 BLISTER PACKTABLET, FILM COATED105
63304-173-30Doxycycline30 in 1 BOTTLETABLET, FILM COATED305
63304-173-69Doxycycline1 in 1 CARTONTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-173-30EA - Each63304-1736bb97874-d205-4ad8-9940-cf2585ff783612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-173DOXYCYCLINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES INC.]5Current NDC, Legacy NDC, 5 package rows20180807_8224b9c5-5c4b-4dda-bc58-47b6604c2884.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSN8224b9c5-5c4b-4dda-bc58-47b6604c28845
1650444doxycycline monohydrate 150 MG Oral TabletPSN8224b9c5-5c4b-4dda-bc58-47b6604c28845
1652673doxycycline monohydrate 50 MG Oral TabletPSN8224b9c5-5c4b-4dda-bc58-47b6604c28845
1649429doxycycline monohydrate 75 MG Oral TabletPSN8224b9c5-5c4b-4dda-bc58-47b6604c28845
1650142doxycycline monohydrate 100 MG Oral TabletSCD8224b9c5-5c4b-4dda-bc58-47b6604c28845
1650444doxycycline monohydrate 150 MG Oral TabletSCD8224b9c5-5c4b-4dda-bc58-47b6604c28845
1652673doxycycline monohydrate 50 MG Oral TabletSCD8224b9c5-5c4b-4dda-bc58-47b6604c28845
1649429doxycycline monohydrate 75 MG Oral TabletSCD8224b9c5-5c4b-4dda-bc58-47b6604c28845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-173-036330401730310 TABLET, FILM COATED in 1 BOTTLE (63304-173-03) 2018-08-060000-00-00NoNoCurrent
63304-173-10633040173101000 TABLET, FILM COATED in 1 BOTTLE (63304-173-10) 2018-08-060000-00-00NoNoCurrent
63304-173-116330401731110 in 1 BLISTER PACKHistorical
63304-173-306330401733030 TABLET, FILM COATED in 1 BOTTLE (63304-173-30) 2018-08-060000-00-00NoNoCurrent
63304-173-69633040173691 BLISTER PACK in 1 CARTON (63304-173-69) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-173-11) 1 blister pack2018-08-060000-00-00NoNoCurrent