Doxycycline

Product NDC
68382-910
11-digit product format
683820910
Labeler code
68382
Product ID
68382-910_b99072cd-f6d8-4d24-9014-f76e327dd6d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA207757
Marketing category
ANDA
Marketing start
2018-02-01
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, 1998483

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
68382-910-10Doxycycline10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1010
68382-910-10Doxycycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-910-10EA - Each68382-9106e5c6ae0-ce54-4372-9b7b-061a55a314a212018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-910DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20250102_7ce80f6e-3c0d-4978-b626-5fd3f3ff349e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310027doxycycline hyclate 100 MG InjectionPSN7ce80f6e-3c0d-4978-b626-5fd3f3ff349e10
1998483doxycycline hyclate 200 MG InjectionPSN7ce80f6e-3c0d-4978-b626-5fd3f3ff349e10
310027doxycycline hyclate 100 MG InjectionSCD7ce80f6e-3c0d-4978-b626-5fd3f3ff349e10
1998483doxycycline hyclate 200 MG InjectionSCD7ce80f6e-3c0d-4978-b626-5fd3f3ff349e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-910-106838209101010 VIAL in 1 CARTON (68382-910-10) / 10 mL in 1 VIAL10 vial2018-02-010000-00-00NoNoCurrent