FDA.reportPublic FDA data

DOXYCYCLINE HYCLATE

Product NDC
23155-611
11-digit product format
231550611
Labeler code
23155
Product ID
23155-611_74ed8d09-3486-4f4f-8df1-ea8f9f380741
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA200856
Marketing category
ANDA
Marketing start
2018-03-16
Substance
DOXYCYCLINE HYCLATE
Active strength
200 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
Brand name suffix
DELAYED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui406524, 434018, 799048, 1423080

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
23155-611-04DOXYCYCLINE HYCLATEDELAYED RELEASE250 in 1 BOTTLETABLET, DELAYED RELEASE25034
23155-611-06DOXYCYCLINE HYCLATEDELAYED RELEASE60 in 1 BOTTLETABLET, DELAYED RELEASE6034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-611-06EA - Each23155-61177d8c878-e1c6-4b4d-9f8b-d0c302fb82ac12019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4DOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6DOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
TRIACETININACTIVE INGREDIENTXHX3C3X673DOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-611DOXYCYCLINE HYCLATE DELAYED RELEASE (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]32Current NDC, Legacy NDC, 2 package rows20231124_f5ee43b2-d6ca-4819-a3d7-07f8421015d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
434018doxycycline hyclate 100 MG Delayed Release Oral TabletPSNf5ee43b2-d6ca-4819-a3d7-07f8421015d734
799048doxycycline hyclate 150 MG Delayed Release Oral TabletPSNf5ee43b2-d6ca-4819-a3d7-07f8421015d734
1423080doxycycline hyclate 200 MG Delayed Release Oral TabletPSNf5ee43b2-d6ca-4819-a3d7-07f8421015d734
406524doxycycline hyclate 75 MG Delayed Release Oral TabletPSNf5ee43b2-d6ca-4819-a3d7-07f8421015d734
434018doxycycline hyclate 100 MG Delayed Release Oral TabletSCDf5ee43b2-d6ca-4819-a3d7-07f8421015d734
799048doxycycline hyclate 150 MG Delayed Release Oral TabletSCDf5ee43b2-d6ca-4819-a3d7-07f8421015d734
1423080doxycycline hyclate 200 MG Delayed Release Oral TabletSCDf5ee43b2-d6ca-4819-a3d7-07f8421015d734
406524doxycycline hyclate 75 MG Delayed Release Oral TabletSCDf5ee43b2-d6ca-4819-a3d7-07f8421015d734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-611-0423155061104250 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-611-04) 2018-03-160000-00-00NoNoCurrent
23155-611-062315506110660 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-611-06) 2018-03-160000-00-00NoNoCurrent