FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
33342-392
11-digit product format
333420392
Labeler code
33342
Product ID
33342-392_2696f799-7902-4239-807a-9ae85a5d0f1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA211418
Marketing category
ANDA
Marketing start
2025-11-19
Substance
DOXYCYCLINE HYCLATE
Active strength
100 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 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
33342-392-05Doxycycline Hyclate20 in 1 BOTTLETABLET201
33342-392-08Doxycycline Hyclate50 in 1 BOTTLETABLET501
33342-392-11Doxycycline Hyclate100 in 1 BOTTLETABLET1001
33342-392-12Doxycycline Hyclate10 in 1 BLISTER PACKTABLET101
33342-392-12Doxycycline Hyclate10 in 1 CARTONTABLET101
33342-392-15Doxycycline Hyclate500 in 1 BOTTLETABLET5001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN2696f799-7902-4239-807a-9ae85a5d0f1d1
1650143doxycycline hyclate 100 MG Oral TabletSCD2696f799-7902-4239-807a-9ae85a5d0f1d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-392-053334203920520 TABLET in 1 BOTTLE (33342-392-05) 20 tablet2025-11-19NoNoCurrent
33342-392-083334203920850 TABLET in 1 BOTTLE (33342-392-08) 50 tablet2025-11-19NoNoCurrent
33342-392-1133342039211100 TABLET in 1 BOTTLE (33342-392-11) 100 tablet2025-11-19NoNoCurrent
33342-392-123334203921210 BLISTER PACK in 1 CARTON (33342-392-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2025-11-19NoNoCurrent
33342-392-1533342039215500 TABLET in 1 BOTTLE (33342-392-15) 500 tablet2025-11-19NoNoCurrent