Doxycycline Hyclate

Product NDC
62332-353
11-digit product format
623320353
Labeler code
62332
Product ID
62332-353_1146adfa-7cd8-4d4f-9ecc-0c1c5a1914f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA210536
Marketing category
ANDA
Marketing start
2020-05-15
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, 1652674

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
62332-353-20Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED2012
62332-353-50Doxycycline Hyclate50 in 1 BOTTLETABLET, FILM COATED5012
62332-353-71Doxycycline Hyclate500 in 1 BOTTLETABLET, FILM COATED50012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-353DOXYCYCLINE HYCLATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 3 package rows20250523_cff08863-7156-49d0-abbd-8f9274302886.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNcff08863-7156-49d0-abbd-8f927430288612
1652674doxycycline hyclate 50 MG Oral TabletPSNcff08863-7156-49d0-abbd-8f927430288612
1650143doxycycline hyclate 100 MG Oral TabletSCDcff08863-7156-49d0-abbd-8f927430288612
1652674doxycycline hyclate 50 MG Oral TabletSCDcff08863-7156-49d0-abbd-8f927430288612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-353-206233203532020 TABLET, FILM COATED in 1 BOTTLE (62332-353-20) 2020-05-150000-00-00NoNoCurrent
62332-353-506233203535050 TABLET, FILM COATED in 1 BOTTLE (62332-353-50) 2020-05-150000-00-00NoNoCurrent
62332-353-7162332035371500 TABLET, FILM COATED in 1 BOTTLE (62332-353-71) 2020-05-150000-00-00NoNoCurrent