FDA.reportPublic FDA data

OFLOXACIN

Product NDC
75834-201
11-digit product format
758340201
Labeler code
75834
Product ID
75834-201_991170ff-e65c-421f-b7f0-95f78e459844
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OFLOXACIN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA091656
Marketing category
ANDA
Marketing start
2019-01-25
Substance
OFLOXACIN
Active strength
400 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OFLOXACIN
Listing expiration
2026-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
41679fed-052c-574b-6b40-cadcbc315b79Product name220150401

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75834-201-012023-07-26C16284748780-1ba0f9c33-0fc4-a910-e053-dadaa90a0b85OFLOXACIN - ofloxacin tablet, USP film coated
75834-201-052023-07-26C16284748780-1ba0f9c33-0fc4-a910-e053-dadaa90a0b85OFLOXACIN - ofloxacin tablet, USP film coated
75834-201-502023-07-26C16284748780-1ba0f9c33-0fc4-a910-e053-dadaa90a0b85OFLOXACIN - ofloxacin tablet, USP film coated
75834-201-012021-01-29C16284748780-1ba0f9c33-0fc4-a910-e053-dadaa90a0b85OFLOXACIN - ofloxacin tablet, USP film coated
75834-201-052021-01-29C16284748780-1ba0f9c33-0fc4-a910-e053-dadaa90a0b85OFLOXACIN - ofloxacin tablet, USP film coated
75834-201-502021-01-29C16284748780-1ba0f9c33-0fc4-a910-e053-dadaa90a0b85OFLOXACIN - ofloxacin tablet, USP film coated

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-201-01OFLOXACIN100 in 1 BOTTLETABLET, COATED1002
75834-201-05OFLOXACIN500 in 1 BOTTLETABLET, COATED5002
75834-201-50OFLOXACIN50 in 1 BOTTLETABLET, COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-201-01EA - Each75834-201e8991983-3264-4f0d-998e-1144cdddc0d912019-03-12
75834-201-50EA - Each75834-20184fffdf8-b482-469e-ae2b-831b37b6c70012019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-201OFLOXACIN TABLET, COATED [NIVAGEN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20230727_1779c568-d7bb-4bd5-bc29-13bd52ba8a0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198048ofloxacin 200 MG Oral TabletPSN1779c568-d7bb-4bd5-bc29-13bd52ba8a0a2
198049ofloxacin 300 MG Oral TabletPSN1779c568-d7bb-4bd5-bc29-13bd52ba8a0a2
198050ofloxacin 400 MG Oral TabletPSN1779c568-d7bb-4bd5-bc29-13bd52ba8a0a2
198048ofloxacin 200 MG Oral TabletSCD1779c568-d7bb-4bd5-bc29-13bd52ba8a0a2
198049ofloxacin 300 MG Oral TabletSCD1779c568-d7bb-4bd5-bc29-13bd52ba8a0a2
198050ofloxacin 400 MG Oral TabletSCD1779c568-d7bb-4bd5-bc29-13bd52ba8a0a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75834-201-0175834020101100 TABLET, COATED in 1 BOTTLE (75834-201-01) 2019-01-25NoNoCurrent
75834-201-0575834020105500 TABLET, COATED in 1 BOTTLE (75834-201-05) 2019-01-25NoNoCurrent
75834-201-507583402015050 TABLET, COATED in 1 BOTTLE (75834-201-50) 2019-01-25NoNoCurrent