Doxycycline Hyclate

Product NDC
68071-4836
11-digit product format
680714836
Labeler code
68071
Product ID
68071-4836_1ae175c6-5f09-8a7a-e063-6294a90a6461
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062269
Marketing category
ANDA
Marketing start
2016-10-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4836-82021-02-17C16284748780-1ba0f9c33-1b53-a910-e053-dadaa90a0b85Doxycycline Hyclate Tablets, USP 100 mg
68071-4836-82021-01-29C16284748780-1ba0f9c33-1b53-a910-e053-dadaa90a0b85Doxycycline Hyclate Tablets, USP 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4836-1Doxycycline Hyclate10 in 1 BOTTLETABLET, FILM COATED105
68071-4836-7Doxycycline Hyclate14 in 1 BOTTLETABLET, FILM COATED145
68071-4836-8Doxycycline Hyclate28 in 1 BOTTLETABLET, FILM COATED285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4836DOXYCYCLINE HYCLATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 3 package rows20240616_860a1566-5857-ed88-e053-2991aa0ae2a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN860a1566-5857-ed88-e053-2991aa0ae2a45
1650143doxycycline hyclate 100 MG Oral TabletSCD860a1566-5857-ed88-e053-2991aa0ae2a45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4836-16807148360110 TABLET, FILM COATED in 1 BOTTLE (68071-4836-1) 2019-04-08NoNoHistorical
68071-4836-76807148360714 TABLET, FILM COATED in 1 BOTTLE (68071-4836-7) 2019-04-080000-00-00NoNoCurrent
68071-4836-86807148360828 TABLET, FILM COATED in 1 BOTTLE (68071-4836-8) 2019-04-080000-00-00NoNoCurrent