Doxycycline

Product NDC
83634-111
11-digit product format
836340111
Labeler code
83634
Product ID
83634-111_60ade7bd-fba3-413c-a82b-904e2ae98b9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Avenacy Inc.
Application
ANDA217854
Marketing category
ANDA
Marketing start
2025-03-01
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
Doxycycline
Listing expiration
2026-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-111-20Doxycycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101
83634-111-41Doxycycline10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-111DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVENACY INC.]1Current NDC, 2 package rows20250302_429813b4-0223-4d85-a844-b1227ff63b1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310027doxycycline hyclate 100 MG InjectionPSN429813b4-0223-4d85-a844-b1227ff63b1e1
310027doxycycline hyclate 100 MG InjectionSCD429813b4-0223-4d85-a844-b1227ff63b1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-111-208363401112010 VIAL, SINGLE-DOSE in 1 CARTON (83634-111-20) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-111-41) 2025-03-01NoNoCurrent
83634-111-418363401114110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical