DOXYCYCLINE HYCLATE

Product NDC
43547-324
11-digit product format
435470324
Labeler code
43547
Product ID
43547-324_49c9be01-a1bf-48aa-8ef4-0584e8dcaac5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Solco Healthcare US LLC
Application
ANDA207494
Marketing category
ANDA
Marketing start
2016-11-28
Substance
DOXYCYCLINE HYCLATE
Active strength
150 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOXYCYCLINE HYCLATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui799048, 1423080, 1653433

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-324-06DOXYCYCLINE HYCLATE60 in 1 BOTTLETABLET, DELAYED RELEASE607
43547-324-10DOXYCYCLINE HYCLATE100 in 1 BOTTLETABLET, DELAYED RELEASE1007
43547-324-50DOXYCYCLINE HYCLATE500 in 1 BOTTLETABLET, DELAYED RELEASE5007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-324DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [SOLCO HEALTHCARE US LLC]4Current NDC, Legacy NDC, 3 package rows20210618_0a18d4c7-9484-4d3e-b61b-e81fe63fefec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
799048doxycycline hyclate 150 MG Delayed Release Oral TabletPSN0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
1423080doxycycline hyclate 200 MG Delayed Release Oral TabletPSN0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
1653433doxycycline hyclate 50 MG Delayed Release Oral TabletPSN0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
799048doxycycline hyclate 150 MG Delayed Release Oral TabletSCD0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
1423080doxycycline hyclate 200 MG Delayed Release Oral TabletSCD0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
1653433doxycycline hyclate 50 MG Delayed Release Oral TabletSCD0a18d4c7-9484-4d3e-b61b-e81fe63fefec7
799048doxycycline hyclate 150 MG Delayed Release Oral TabletPSN4fa26176-a730-48ed-9659-e2f64212f4183
799048doxycycline hyclate 150 MG Delayed Release Oral TabletSCD4fa26176-a730-48ed-9659-e2f64212f4183

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-324-064354703240660 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-06) 2016-11-280000-00-00NoNoCurrent
43547-324-1043547032410100 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-10) 2016-11-280000-00-00NoNoCurrent
43547-324-5043547032450500 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-50) 2016-11-280000-00-00NoNoCurrent