Doxycycline

Product NDC
71288-030
11-digit product format
712880030
Labeler code
71288
Product ID
71288-030_74ad3c76-a6cf-44a3-805e-cfae1d1a6560
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA218053
Marketing category
ANDA
Marketing start
2024-10-28
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
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
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
71288-030-20Doxycycline10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,106
71288-030-21Doxycycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-030-20EA - Each71288-0309e6f280e-a104-4761-acb2-cbbeac61d23d12024-12-10
71288-030-21EA - Each71288-03017a5a3ac-f00a-421c-9255-c5a83edf9cdf12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-030DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, 2 package rows20241109_7772e702-20b3-473a-8bd5-9c7c92e753c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310027doxycycline hyclate 100 MG InjectionPSN7772e702-20b3-473a-8bd5-9c7c92e753c66
310027doxycycline hyclate 100 MG InjectionSCD7772e702-20b3-473a-8bd5-9c7c92e753c66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-030-207128800302010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
71288-030-217128800302110 VIAL, SINGLE-DOSE in 1 CARTON (71288-030-21) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-030-20) 2024-10-28NoNoCurrent