FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
67296-1456
11-digit product format
672961456
Labeler code
67296
Product ID
67296-1456_2c623075-374e-8623-e063-6294a90ac3ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Redpharm Drug, Inc.
Application
ANDA062505
Marketing category
ANDA
Marketing start
1984-09-11
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
67296-1456-22025-01-30C16284748780-12cef2736-9963-d83d-e063-dadaa90ab31fDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1456-4Doxycycline Hyclate14 in 1 BOTTLETABLET, FILM COATED143
67296-1456-2Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1456DOXYCYCLINE HYCLATE TABLET, FILM COATED [REDPHARM DRUG, INC.]3Current NDC, 1 package rows20250124_09d19663-a8b9-0c3f-e063-6394a90aa446.zip
67296-1456DOXYCYCLINE HYCLATE TABLET, FILM COATED [REDPHARM DRUG, INC.]1Current NDC, 1 package rows20230208_f4239c08-f324-61f8-e053-2995a90adebe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN09d19663-a8b9-0c3f-e063-6394a90aa4463
1650143doxycycline hyclate 100 MG Oral TabletSCD09d19663-a8b9-0c3f-e063-6394a90aa4463
1650143doxycycline hyclate 100 MG Oral TabletPSNf4239c08-f324-61f8-e053-2995a90adebe1
1650143doxycycline hyclate 100 MG Oral TabletSCDf4239c08-f324-61f8-e053-2995a90adebe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67296-1456-26729614560220 in 1 BOTTLEHistorical
67296-1456-46729614560414 TABLET, FILM COATED in 1 BOTTLE (67296-1456-4) 1984-09-11NoNoHistorical