FDA.reportPublic FDA data

DOXYCYCLINE HYCLATE

Product NDC
68071-3466
11-digit product format
680713466
Labeler code
68071
Product ID
68071-3466_05a89a71-88dd-f4e0-e063-6294a90ae89f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA211343
Marketing category
ANDA
Marketing start
2019-10-09
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
68071-3466-1DOXYCYCLINE HYCLATE10 in 1 BOTTLETABLET103
68071-3466-7DOXYCYCLINE HYCLATE14 in 1 BOTTLETABLET143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3466DOXYCYCLINE HYCLATE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 2 package rows20240922_0106a3d3-db4d-f6ee-e063-6294a90a25e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN0106a3d3-db4d-f6ee-e063-6294a90a25e93
1650143doxycycline hyclate 100 MG Oral TabletSCD0106a3d3-db4d-f6ee-e063-6294a90a25e93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3466-16807134660110 TABLET in 1 BOTTLE (68071-3466-1) 10 tablet2023-07-21NoNoHistorical
68071-3466-76807134660714 TABLET in 1 BOTTLE (68071-3466-7) 14 tablet2023-07-21NoNoHistorical