FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
69238-1100
11-digit product format
692381100
Labeler code
69238
Product ID
69238-1100_a8b74462-290d-4e0f-9611-ebbb5f6214d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA207289
Marketing category
ANDA
Marketing start
2016-06-28
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
Rxcui1649988

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1100-2Doxycycline Hyclate50 in 1 BOTTLECAPSULE5015
69238-1100-5Doxycycline Hyclate500 in 1 BOTTLECAPSULE50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1100-2EA - Each69238-11008e23268f-97aa-48a5-8962-1c79c7883eb512016-09-02
69238-1100-5EA - Each69238-1100e4f52ac2-640f-46e9-8faa-2b5d935bdb0012016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1100DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]14Current NDC, Legacy NDC, 2 package rows20250515_79f3c026-7687-4a11-8d2e-03493531d3bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN79f3c026-7687-4a11-8d2e-03493531d3bf15
1649988doxycycline hyclate 100 MG Oral CapsuleSCD79f3c026-7687-4a11-8d2e-03493531d3bf15
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY79f3c026-7687-4a11-8d2e-03493531d3bf15
1649988doxycycline hyclate 100 MG Oral CapsulePSNf9a9a558-4063-4aa7-9191-3875c97cf49a6
1649988doxycycline hyclate 100 MG Oral CapsulePSNb4f2ab4f-c32b-6435-e053-2995a90a69b66
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf9a9a558-4063-4aa7-9191-3875c97cf49a6
1649988doxycycline hyclate 100 MG Oral CapsuleSCDb4f2ab4f-c32b-6435-e053-2995a90a69b66
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf9a9a558-4063-4aa7-9191-3875c97cf49a6
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYb4f2ab4f-c32b-6435-e053-2995a90a69b66
1649988doxycycline hyclate 100 MG Oral CapsulePSN34907713-088d-4434-b2cb-cb6c448092ef5
1649988doxycycline hyclate 100 MG Oral CapsuleSCD34907713-088d-4434-b2cb-cb6c448092ef5
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY34907713-088d-4434-b2cb-cb6c448092ef5
1649988doxycycline hyclate 100 MG Oral CapsulePSNb2e97e39-a462-710f-e053-2995a90a9aa64
1649988doxycycline hyclate 100 MG Oral CapsulePSN696f8eba-68c5-8f1c-e053-2991aa0a11244
1649988doxycycline hyclate 100 MG Oral CapsulePSNe2151005-fb4a-485d-88ad-b44c4594d5794
1649988doxycycline hyclate 100 MG Oral CapsuleSCD696f8eba-68c5-8f1c-e053-2991aa0a11244
1649988doxycycline hyclate 100 MG Oral CapsuleSCDb2e97e39-a462-710f-e053-2995a90a9aa64
1649988doxycycline hyclate 100 MG Oral CapsuleSCDe2151005-fb4a-485d-88ad-b44c4594d5794
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYb2e97e39-a462-710f-e053-2995a90a9aa64
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY696f8eba-68c5-8f1c-e053-2991aa0a11244
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYe2151005-fb4a-485d-88ad-b44c4594d5794
1649988doxycycline hyclate 100 MG Oral CapsulePSNb73d4bc5-6014-4af2-80fc-12da87d19b3a2
1649988doxycycline hyclate 100 MG Oral CapsuleSCDb73d4bc5-6014-4af2-80fc-12da87d19b3a2
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYb73d4bc5-6014-4af2-80fc-12da87d19b3a2
1649988doxycycline hyclate 100 MG Oral CapsulePSN6580d3c8-0801-4cb6-b4fc-47fd69b484151
1649988doxycycline hyclate 100 MG Oral CapsuleSCD6580d3c8-0801-4cb6-b4fc-47fd69b484151
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY6580d3c8-0801-4cb6-b4fc-47fd69b484151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1100-169238110001100 CAPSULE in 1 BOTTLE (69238-1100-1) 100 capsule2016-06-280000-00-00NoNoCurrent
69238-1100-26923811000250 CAPSULE in 1 BOTTLE (69238-1100-2) 50 capsule2016-06-280000-00-00NoNoCurrent
69238-1100-36923811000320 CAPSULE in 1 BOTTLE (69238-1100-3) 20 capsule2016-06-280000-00-00NoNoCurrent
69238-1100-569238110005500 CAPSULE in 1 BOTTLE (69238-1100-5) 500 capsule2016-06-280000-00-00NoNoCurrent