FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
67296-0329
11-digit product format
672960329
Labeler code
67296
Product ID
67296-0329_bdaeb94d-b7b0-1da6-e053-2a95a90a94ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA062677
Marketing category
ANDA
Marketing start
1986-07-10
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
67296-0329-22026-01-29C16284748780-1f386c649-f237-0266-e053-dadaa90a7c1aDoxycycline hyclate 100mg tabs
67296-0329-32026-01-29C16284748780-1f386c649-f237-0266-e053-dadaa90a7c1aDoxycycline hyclate 100mg tabs
67296-0329-42026-01-29C16284748780-1f386c649-f237-0266-e053-dadaa90a7c1aDoxycycline hyclate 100mg tabs
67296-0329-22024-06-19C16284748780-1f386c649-f237-0266-e053-dadaa90a7c1aDoxycycline hyclate 100mg tabs
67296-0329-32024-06-19C16284748780-1f386c649-f237-0266-e053-dadaa90a7c1aDoxycycline hyclate 100mg tabs
67296-0329-42024-06-19C16284748780-1f386c649-f237-0266-e053-dadaa90a7c1aDoxycycline hyclate 100mg tabs
67296-0329-22023-01-30C16284748780-1f386c649-f237-0266-e053-dadaa90a7c1aDoxycycline hyclate 100mg tabs
67296-0329-32023-01-30C16284748780-1f386c649-f237-0266-e053-dadaa90a7c1aDoxycycline hyclate 100mg tabs
67296-0329-42023-01-30C16284748780-1f386c649-f237-0266-e053-dadaa90a7c1aDoxycycline hyclate 100mg tabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0329-2Doxycycline Hyclate14 in 1 BOTTLETABLET, FILM COATED142
67296-0329-3Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED202
67296-0329-4Doxycycline Hyclate2 in 1 BOTTLETABLET, FILM COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0329DOXYCYCLINE HYCLATE TABLET, FILM COATED [REDPHARM DRUG, INC.]2Legacy NDC, 3 package rows20240620_bdaeb1eb-2f7b-3072-e053-2995a90acbd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNbdaeb1eb-2f7b-3072-e053-2995a90acbd82
1650143doxycycline hyclate 100 MG Oral TabletSCDbdaeb1eb-2f7b-3072-e053-2995a90acbd82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-0329-26729603290214 TABLET, FILM COATED in 1 BOTTLE (67296-0329-2) 1986-07-100000-00-00NoNoCurrent
67296-0329-36729603290320 TABLET, FILM COATED in 1 BOTTLE (67296-0329-3) 1986-07-100000-00-00NoNoCurrent
67296-0329-4672960329042 TABLET, FILM COATED in 1 BOTTLE (67296-0329-4) 1986-07-100000-00-00NoNoCurrent