DOXYCYCLINE

Product NDC
0404-9855
11-digit product format
004049855
Labeler code
0404
Product ID
0404-9855_b372de2b-d9ea-4e3d-8a18-5e947d2a0078
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Henry Schein, Inc
Application
ANDA091406
Marketing category
ANDA
Marketing start
2022-01-10
Marketing end
2027-03-31
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/10mL
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOXYCYCLINE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui310027

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
0404-9855-99DOXYCYCLINE10 mL in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,105
0404-9855-99DOXYCYCLINE1 in 1 BAGINJECTION, POWDER, LYOPHILIZED,15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9855DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HENRY SCHEIN, INC]4Current NDC, Legacy NDC, 2 package rows20241018_dd70368b-1949-4833-9d1e-f9f4cdacd9f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310027doxycycline hyclate 100 MG InjectionPSNdd70368b-1949-4833-9d1e-f9f4cdacd9f35
310027doxycycline hyclate 100 MG InjectionSCDdd70368b-1949-4833-9d1e-f9f4cdacd9f35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9855-99004049855991 PACKAGE in 1 BAG (0404-9855-99) / 10 mL in 1 PACKAGE1 package2022-01-102027-03-31NoNoCurrent