Doxycycline Hyclate

Product NDC
40032-794
11-digit product format
400320794
Labeler code
40032
Product ID
40032-794_7511bdc8-a3f6-4f22-bad9-72d861c711c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA207558
Marketing category
ANDA
Marketing start
2017-09-06
Substance
DOXYCYCLINE HYCLATE
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 Hyclate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1650143

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
40032-794-01Doxycycline Hyclate100 in 1 BOTTLETABLET1004
40032-794-02Doxycycline Hyclate20 in 1 BOTTLETABLET204
40032-794-05Doxycycline Hyclate500 in 1 BOTTLETABLET5004
40032-794-10Doxycycline Hyclate1000 in 1 BOTTLETABLET10004
40032-794-50Doxycycline Hyclate50 in 1 BOTTLETABLET504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-794DOXYCYCLINE HYCLATE TABLET [NOVEL LABORATORIES, INC.]4Current NDC, Legacy NDC, 5 package rows20181207_25a92544-1421-4ccb-a49c-11742851f214.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN25a92544-1421-4ccb-a49c-11742851f2144
1650143doxycycline hyclate 100 MG Oral TabletSCD25a92544-1421-4ccb-a49c-11742851f2144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-794-0140032079401100 TABLET in 1 BOTTLE (40032-794-01) 100 tablet2017-09-060000-00-00NoNoCurrent
40032-794-024003207940220 TABLET in 1 BOTTLE (40032-794-02) 20 tablet2017-09-060000-00-00NoNoCurrent
40032-794-0540032079405500 TABLET in 1 BOTTLE (40032-794-05) 500 tablet2017-09-060000-00-00NoNoCurrent
40032-794-10400320794101000 TABLET in 1 BOTTLE (40032-794-10) 1000 tablet2018-02-130000-00-00NoNoCurrent
40032-794-504003207945050 TABLET in 1 BOTTLE (40032-794-50) 50 tablet2017-09-060000-00-00NoNoCurrent