Doxycycline Hyclate

Product NDC
62332-481
11-digit product format
623320481
Labeler code
62332
Product ID
62332-481_79225960-dfaf-43a0-8698-9c83ee345ea6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA213075
Marketing category
ANDA
Marketing start
2022-01-04
Substance
DOXYCYCLINE HYCLATE
Active strength
75 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE75 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
62332-481-31Doxycycline Hyclate100 in 1 BOTTLETABLET, DELAYED RELEASE1009
62332-481-60Doxycycline Hyclate60 in 1 BOTTLETABLET, DELAYED RELEASE609
62332-481-91Doxycycline Hyclate1000 in 1 BOTTLETABLET, DELAYED RELEASE10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-481DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 3 package rows20230411_3ae4ca12-be39-46b9-bc4c-f8356776c175.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
434018doxycycline hyclate 100 MG Delayed Release Oral TabletPSN3ae4ca12-be39-46b9-bc4c-f8356776c1759
799048doxycycline hyclate 150 MG Delayed Release Oral TabletPSN3ae4ca12-be39-46b9-bc4c-f8356776c1759
1423080doxycycline hyclate 200 MG Delayed Release Oral TabletPSN3ae4ca12-be39-46b9-bc4c-f8356776c1759
406524doxycycline hyclate 75 MG Delayed Release Oral TabletPSN3ae4ca12-be39-46b9-bc4c-f8356776c1759
434018doxycycline hyclate 100 MG Delayed Release Oral TabletSCD3ae4ca12-be39-46b9-bc4c-f8356776c1759
799048doxycycline hyclate 150 MG Delayed Release Oral TabletSCD3ae4ca12-be39-46b9-bc4c-f8356776c1759
1423080doxycycline hyclate 200 MG Delayed Release Oral TabletSCD3ae4ca12-be39-46b9-bc4c-f8356776c1759
406524doxycycline hyclate 75 MG Delayed Release Oral TabletSCD3ae4ca12-be39-46b9-bc4c-f8356776c1759

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-481-3162332048131100 TABLET, DELAYED RELEASE in 1 BOTTLE (62332-481-31) 2022-01-040000-00-00NoNoCurrent
62332-481-606233204816060 TABLET, DELAYED RELEASE in 1 BOTTLE (62332-481-60) 2022-01-040000-00-00NoNoCurrent
62332-481-91623320481911000 TABLET, DELAYED RELEASE in 1 BOTTLE (62332-481-91) 2022-01-040000-00-00NoNoCurrent