OFLOXACIN

Product NDC
72241-074
11-digit product format
722410074
Labeler code
72241
Product ID
72241-074_5edb8648-37ed-49de-825c-a3d66e5aa4c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OFLOXACIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA091656
Marketing category
ANDA
Marketing start
2025-06-24
Substance
OFLOXACIN
Active strength
400 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OFLOXACIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA4P49JAZ9H
Rxcui198048, 198049, 198050

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f9d82093-3de1-4841-9a42-67222d61a0cfProduct name420250515
bbed5f06-a6b7-a443-70ac-77518a9524b7Product name720250311
41679fed-052c-574b-6b40-cadcbc315b79Product name220150401

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72241-074-02OFLOXACIN100 in 1 BOTTLETABLET, FILM COATED1002
72241-074-05OFLOXACIN500 in 1 BOTTLETABLET, FILM COATED5002
72241-074-10OFLOXACIN50 in 1 BOTTLETABLET, FILM COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-074-02EA - Each72241-074d2cb4241-f0f8-44e5-bdda-7199ae7c36e412026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198048ofloxacin 200 MG Oral TabletPSN93ed9f70-b44f-496b-bdfc-c1bd5f1c260b2
198049ofloxacin 300 MG Oral TabletPSN93ed9f70-b44f-496b-bdfc-c1bd5f1c260b2
198050ofloxacin 400 MG Oral TabletPSN93ed9f70-b44f-496b-bdfc-c1bd5f1c260b2
198048ofloxacin 200 MG Oral TabletSCD93ed9f70-b44f-496b-bdfc-c1bd5f1c260b2
198049ofloxacin 300 MG Oral TabletSCD93ed9f70-b44f-496b-bdfc-c1bd5f1c260b2
198050ofloxacin 400 MG Oral TabletSCD93ed9f70-b44f-496b-bdfc-c1bd5f1c260b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72241-074-0272241007402100 TABLET, FILM COATED in 1 BOTTLE (72241-074-02) 2025-06-24NoNoCurrent
72241-074-0572241007405500 TABLET, FILM COATED in 1 BOTTLE (72241-074-05) 2025-06-24NoNoCurrent
72241-074-107224100741050 TABLET, FILM COATED in 1 BOTTLE (72241-074-10) 2025-06-24NoNoCurrent