FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
46708-499
11-digit product format
467080499
Labeler code
46708
Product ID
46708-499_8a6d5c0f-9b8e-444e-882e-8a2264410c02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA210536
Marketing category
ANDA
Marketing start
2021-09-15
Substance
DOXYCYCLINE HYCLATE
Active strength
50 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 HYCLATE50 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-499-602023-02-01C16284748780-1f386c649-f28f-0266-e053-dadaa90a7c1aDoxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
46708-499-602023-01-30C16284748780-1f386c649-f28f-0266-e053-dadaa90a7c1aDoxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-499-60Doxycycline Hyclate60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-499DOXYCYCLINE HYCLATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 1 package rows20230202_24c8472a-dd07-4f84-8bea-20a3f178d119.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN24c8472a-dd07-4f84-8bea-20a3f178d1193
1652674doxycycline hyclate 50 MG Oral TabletPSN24c8472a-dd07-4f84-8bea-20a3f178d1193
1650143doxycycline hyclate 100 MG Oral TabletSCD24c8472a-dd07-4f84-8bea-20a3f178d1193
1652674doxycycline hyclate 50 MG Oral TabletSCD24c8472a-dd07-4f84-8bea-20a3f178d1193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-499-604670804996060 TABLET, FILM COATED in 1 BOTTLE (46708-499-60) 2021-09-150000-00-00NoNoCurrent