DOXYCYCLINE

Product NDC
43598-086
11-digit product format
435980086
Labeler code
43598
Product ID
43598-086_d81118bc-54c2-51cd-4ddd-d3afcf12ddf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories, Inc.
Application
ANDA218753
Marketing category
ANDA
Marketing start
2025-07-18
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/10mL
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOXYCYCLINE
Brand name suffix
DOXYCYCLINE
Listing expiration
2027-12-31

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
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
43598-086-58DOXYCYCLINE DOXYCYCLINE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,105
43598-086-58DOXYCYCLINE DOXYCYCLINE10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-086-58EA - Each43598-086a0126a42-fd4d-4d9f-b924-b5bf0deaa2f412025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310027doxycycline hyclate 100 MG InjectionPSNc0206e91-d87f-311c-80dc-aad543d001e85
310027doxycycline hyclate 100 MG InjectionSCDc0206e91-d87f-311c-80dc-aad543d001e85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-086-584359800865810 VIAL, SINGLE-DOSE in 1 CARTON (43598-086-58) / 10 mL in 1 VIAL, SINGLE-DOSE2025-07-18NoNoCurrent