FDA.reportPublic FDA data

Doxy 100

Product NDC
63323-130
11-digit product format
633230130
Labeler code
63323
Product ID
63323-130_22ec807c-14e3-4b73-baa8-931ade7d3203
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA062475
Marketing category
ANDA
Marketing start
2000-10-17
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/10mL
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
Doxy 100
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui310027, 544840

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
63323-130-02Doxy 10010 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,108
63323-130-11Doxy 10010 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,108
63323-130-03Doxy 10010 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,105
63323-130-13Doxy 10010 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,105
63323-130-17Doxy 10010 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,103
63323-130-41Doxy 10010 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-130-02EA - Each63323-130edc7cbba-452b-471d-8d2b-4a2a363804bd12021-08-05
63323-130-03EA - Each63323-130a20d17a4-29c2-4d0e-9ea1-581bd979c32112021-09-07
63323-130-11EA - Each63323-13048113d52-439a-4a9f-b934-26c54770a14a12013-02-13
63323-130-13EA - Each63323-1307698ad16-4f9a-4a8a-a05b-b70c7a026c5312013-09-04
63323-130-17EA - Each63323-1309f82722c-19ff-46b8-9323-dabe43b1386112014-12-01
63323-130-41EA - Each63323-1308403a847-92ed-40b5-ad20-d703f943c9e212022-01-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RDOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ADOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RDOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ADOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RDOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-130DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 2 package rows20200610_b0894010-39bd-459f-8563-cf83343105ee.zip
63323-130DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]5Current NDC, Legacy NDC, 2 package rows20210312_b256babb-1bba-4b0c-8837-d13ba3af7659.zip
63323-130DOXY 100 (DOXYCYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]3Current NDC, Legacy NDC, 2 package rows20210204_a7b754e2-a028-469d-ba95-8412ef03ab0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
544840Doxy 100, 100 MG InjectionPSNb0894010-39bd-459f-8563-cf83343105ee8
310027doxycycline hyclate 100 MG InjectionPSNb0894010-39bd-459f-8563-cf83343105ee8
544840doxycycline hyclate 100 MG Injection [Doxy]SBDb0894010-39bd-459f-8563-cf83343105ee8
310027doxycycline hyclate 100 MG InjectionSCDb0894010-39bd-459f-8563-cf83343105ee8
544840Doxy 10 MG/ML Injectable SolutionSYb0894010-39bd-459f-8563-cf83343105ee8
544840Doxy 100, 10 MG/ML Injectable SolutionSYb0894010-39bd-459f-8563-cf83343105ee8
544840Doxy 100, 100 MG InjectionSYb0894010-39bd-459f-8563-cf83343105ee8
544840Doxy 100, 100 MG per 10 ML Injectable SolutionSYb0894010-39bd-459f-8563-cf83343105ee8
544840Doxy 100, 100 MG InjectionPSNb256babb-1bba-4b0c-8837-d13ba3af76595
310027doxycycline hyclate 100 MG InjectionPSNb256babb-1bba-4b0c-8837-d13ba3af76595
544840doxycycline hyclate 100 MG Injection [Doxy]SBDb256babb-1bba-4b0c-8837-d13ba3af76595
310027doxycycline hyclate 100 MG InjectionSCDb256babb-1bba-4b0c-8837-d13ba3af76595
544840Doxy 10 MG/ML Injectable SolutionSYb256babb-1bba-4b0c-8837-d13ba3af76595
544840Doxy 100, 10 MG/ML Injectable SolutionSYb256babb-1bba-4b0c-8837-d13ba3af76595
544840Doxy 100, 100 MG InjectionSYb256babb-1bba-4b0c-8837-d13ba3af76595
544840Doxy 100, 100 MG per 10 ML Injectable SolutionSYb256babb-1bba-4b0c-8837-d13ba3af76595
310027doxycycline hyclate 100 MG InjectionPSN9454f948-584f-59de-e053-2a95a90a9f014
310027doxycycline hyclate 100 MG InjectionSCD9454f948-584f-59de-e053-2a95a90a9f014
544840Doxy 100, 100 MG InjectionPSNa7b754e2-a028-469d-ba95-8412ef03ab0a3
310027doxycycline hyclate 100 MG InjectionPSNa7b754e2-a028-469d-ba95-8412ef03ab0a3
544840doxycycline hyclate 100 MG Injection [Doxy]SBDa7b754e2-a028-469d-ba95-8412ef03ab0a3
310027doxycycline hyclate 100 MG InjectionSCDa7b754e2-a028-469d-ba95-8412ef03ab0a3
544840Doxy 10 MG/ML Injectable SolutionSYa7b754e2-a028-469d-ba95-8412ef03ab0a3
544840Doxy 100, 10 MG/ML Injectable SolutionSYa7b754e2-a028-469d-ba95-8412ef03ab0a3
544840Doxy 100, 100 MG InjectionSYa7b754e2-a028-469d-ba95-8412ef03ab0a3
544840Doxy 100, 100 MG per 10 ML Injectable SolutionSYa7b754e2-a028-469d-ba95-8412ef03ab0a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-130-026332301300210 mL in 1 VIAL10 mlHistorical
63323-130-036332301300310 mL in 1 VIAL10 mlHistorical
63323-130-116332301301110 VIAL in 1 TRAY (63323-130-11) / 10 mL in 1 VIAL (63323-130-02) 10 vial2000-10-170000-00-00NoNoCurrent
63323-130-136332301301310 VIAL in 1 TRAY (63323-130-13) / 10 mL in 1 VIAL (63323-130-03) 10 vial2000-10-170000-00-00NoNoCurrent
63323-130-176332301301710 VIAL in 1 TRAY (63323-130-17) / 10 mL in 1 VIAL (63323-130-41) 10 vial2000-10-170000-00-00NoNoCurrent
63323-130-416332301304110 mL in 1 VIAL10 mlHistorical