FDA.reportPublic FDA data

DOXYCYCLINE HYCLATE

Product NDC
27808-234
11-digit product format
278080234
Labeler code
27808
Product ID
27808-234_03cb5078-768e-41a1-b922-f1dee98e8760
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
TABLET
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA211343
Marketing category
ANDA
Marketing start
2019-10-09
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27808-234-01DOXYCYCLINE HYCLATE50 in 1 BOTTLETABLET502
27808-234-02DOXYCYCLINE HYCLATE500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-234-01EA - Each27808-234a33a57a2-ee39-44b1-954f-21d52ce4299612022-04-06
27808-234-02EA - Each27808-234ef1ccbe8-63f1-4f95-8c7e-2af61232250c12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-234DOXYCYCLINE HYCLATE TABLET [TRIS PHARMA INC]1Current NDC, Legacy NDC, 2 package rows20220215_fe6985d2-37f7-4277-94a9-f7125b4b3fd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNe726157e-ce44-4df3-8161-7016700dd751104
1650143doxycycline hyclate 100 MG Oral TabletSCDe726157e-ce44-4df3-8161-7016700dd751104
1650143doxycycline hyclate 100 MG Oral TabletPSNfd58dbe5-aab2-4378-b054-d5c60d87074e100
1650143doxycycline hyclate 100 MG Oral TabletPSN7a915c50-6fce-45e6-9554-677bb09a868d100
1650143doxycycline hyclate 100 MG Oral TabletSCDfd58dbe5-aab2-4378-b054-d5c60d87074e100
1650143doxycycline hyclate 100 MG Oral TabletSCD7a915c50-6fce-45e6-9554-677bb09a868d100
1650143doxycycline hyclate 100 MG Oral TabletPSN5fdc01c3-c62f-40cf-8351-91cbcc43d37913
1650143doxycycline hyclate 100 MG Oral TabletSCD5fdc01c3-c62f-40cf-8351-91cbcc43d37913
1650143doxycycline hyclate 100 MG Oral TabletPSN0106a3d3-db4d-f6ee-e063-6294a90a25e93
1650143doxycycline hyclate 100 MG Oral TabletPSN02f87c60-8425-1a1e-e063-6294a90a0c943
1650143doxycycline hyclate 100 MG Oral TabletPSN1a3c713f-bc4f-4848-e063-6394a90a02723
1650143doxycycline hyclate 100 MG Oral TabletSCD02f87c60-8425-1a1e-e063-6294a90a0c943
1650143doxycycline hyclate 100 MG Oral TabletSCD0106a3d3-db4d-f6ee-e063-6294a90a25e93
1650143doxycycline hyclate 100 MG Oral TabletSCD1a3c713f-bc4f-4848-e063-6394a90a02723
1650143doxycycline hyclate 100 MG Oral TabletPSNfe6985d2-37f7-4277-94a9-f7125b4b3fd72
1650143doxycycline hyclate 100 MG Oral TabletPSNdb521288-b67d-48fd-9d07-3e7f301e60cd2
1650143doxycycline hyclate 100 MG Oral TabletPSN2ad2b85f-2479-c7cd-e063-6294a90acca12
1650143doxycycline hyclate 100 MG Oral TabletPSN0b251a58-30d8-dfec-e063-6294a90a3b452
1650143doxycycline hyclate 100 MG Oral TabletSCDdb521288-b67d-48fd-9d07-3e7f301e60cd2
1650143doxycycline hyclate 100 MG Oral TabletSCD2ad2b85f-2479-c7cd-e063-6294a90acca12
1650143doxycycline hyclate 100 MG Oral TabletSCDfe6985d2-37f7-4277-94a9-f7125b4b3fd72
1650143doxycycline hyclate 100 MG Oral TabletSCD0b251a58-30d8-dfec-e063-6294a90a3b452
1650143doxycycline hyclate 100 MG Oral TabletPSNd421b771-de88-4769-949f-8a24baa69c251
1650143doxycycline hyclate 100 MG Oral TabletPSNe38f3cd2-47e5-438f-bbe3-50b578360f741
1650143doxycycline hyclate 100 MG Oral TabletPSN97d25310-d19f-4bde-a03e-d464ebb2a6bf1
1650143doxycycline hyclate 100 MG Oral TabletSCDd421b771-de88-4769-949f-8a24baa69c251
1650143doxycycline hyclate 100 MG Oral TabletSCD97d25310-d19f-4bde-a03e-d464ebb2a6bf1
1650143doxycycline hyclate 100 MG Oral TabletSCDe38f3cd2-47e5-438f-bbe3-50b578360f741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-234-012780802340150 TABLET in 1 BOTTLE (27808-234-01) 50 tablet2022-02-140000-00-00NoNoCurrent
27808-234-0227808023402500 TABLET in 1 BOTTLE (27808-234-02) 500 tablet2022-02-140000-00-00NoNoCurrent