FDA.reportPublic FDA data

Doxycycline

Product NDC
23155-135
11-digit product format
231550135
Labeler code
23155
Product ID
23155-135_ec6854e5-3f41-4b8f-be77-49e3bd19f7c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA091605
Marketing category
ANDA
Marketing start
2012-05-01
Substance
DOXYCYCLINE
Active strength
100 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
DOXYCYCLINE100 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
23155-135-05Doxycycline500 in 1 BOTTLETABLET50018
23155-135-11Doxycycline10 in 1 BLISTER PACKTABLET1018
23155-135-25Doxycycline50 in 1 BOTTLETABLET5018
23155-135-30Doxycycline30 in 1 CARTONTABLET3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-135-05EA - Each23155-135fb2f9139-4f96-4d75-b394-5dc64804dc6412018-06-11
23155-135-25EA - Each23155-135894da63b-b831-40be-ba52-4f26b69f895e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODIRECT RX (DOXYCYCLINE) TABLET [DIRECT RX]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DIRECT RX (DOXYCYCLINE) TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-135DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 4 package rows20241130_2bcde264-5f6f-47f6-ae2e-1b7010deacf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSN2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1650444doxycycline monohydrate 150 MG Oral TabletPSN2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1652673doxycycline monohydrate 50 MG Oral TabletPSN2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1649429doxycycline monohydrate 75 MG Oral TabletPSN2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1650142doxycycline monohydrate 100 MG Oral TabletSCD2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1650444doxycycline monohydrate 150 MG Oral TabletSCD2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1652673doxycycline monohydrate 50 MG Oral TabletSCD2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1649429doxycycline monohydrate 75 MG Oral TabletSCD2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1650142doxycycline monohydrate 100 MG Oral TabletPSN2b3b3c48-eb60-400c-bdfe-50635a136c9011
1650142doxycycline monohydrate 100 MG Oral TabletSCD2b3b3c48-eb60-400c-bdfe-50635a136c9011
1650142doxycycline monohydrate 100 MG Oral TabletPSN3f51c8ca-bf19-48b8-ac69-3830bff450873
1650142doxycycline monohydrate 100 MG Oral TabletPSNf2f1ee15-9323-1263-e053-2995a90a01fa3
1650142doxycycline monohydrate 100 MG Oral TabletSCD3f51c8ca-bf19-48b8-ac69-3830bff450873
1650142doxycycline monohydrate 100 MG Oral TabletSCDf2f1ee15-9323-1263-e053-2995a90a01fa3
1650142doxycycline monohydrate 100 MG Oral TabletPSN112c35d6-a397-45de-a57a-6e687cb27b4f1
1650142doxycycline monohydrate 100 MG Oral TabletSCD112c35d6-a397-45de-a57a-6e687cb27b4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-135-0523155013505500 TABLET in 1 BOTTLE (23155-135-05) 500 tablet2012-05-010000-00-00NoNoCurrent
23155-135-112315501351110 TABLET in 1 BLISTER PACK (23155-135-11) 10 tablet2012-05-010000-00-00NoNoCurrent
23155-135-252315501352550 TABLET in 1 BOTTLE (23155-135-25) 50 tablet2012-05-010000-00-00NoNoCurrent
23155-135-302315501353030 TABLET in 1 CARTON (23155-135-30) 30 tablet2012-05-010000-00-00NoNoCurrent