FDA.reportPublic FDA data

levofloxacin

Product NDC
67046-1078
11-digit product format
670461078
Labeler code
67046
Product ID
67046-1078_2cee69f0-e493-7eb5-e063-6394a90a4b99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA077652
Marketing category
ANDA
Marketing start
2025-01-30
Substance
LEVOFLOXACIN
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077652-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2012-09-07
A077652-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2012-09-07
A077652-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALAB2012-09-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077652-001AB
A077652-002AB
A077652-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07a50c72e98297…
2026-08-01 22:54:322026-06A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07a50c72e98297…
2026-08-01 22:54:322026-06A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077652-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077652-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077652-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levofloxacinLEVOFLOXACINRedpharm Drug5261da15-1b6c-fbe2-e063-6394a90ad85e2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINRedpharm Drug44f31105-5fc9-43d4-e063-6294a90a510f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINREMEDYREPACK INC.264a3f71-f23e-45e3-926a-421bcccf4e3d2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc.7a12135e-cbad-4fe1-98f7-53c41d1f2a212026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINRedpharm Drug301ecffc-ecaf-01de-e063-6294a90a61b32025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINBryant Ranch Prepackcbd5153f-fada-4682-b858-dc3b6e3173cc2025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINCoupler LLC2cee61b7-be51-0fe5-e063-6294a90af9e32025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
ndc (product): 67046-1078
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc067e260c-dc47-4957-a9ff-5a79f17b4ca02025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINBryant Ranch Prepackb7a614b0-f604-48e1-9919-21da8f939d932024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINZydus Lifesciences Limitedffa121b8-388f-4d7b-af48-d4aa8d9b59612024-08-16Exact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINViona Pharmaceuticals Inc0948bff7-efc6-4f0e-a9dd-adca5bdc7fc22024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
LevofloxacinLLEVOFLOXACINAdvanced Rx Pharmacy of Tennessee, LLC19afbe98-484c-c980-e063-6294a90acdc62024-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6GNT3Y5LMFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199884Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cee61b7-be51-0fe5-e063-6294a90af9e3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
addb5519-f7ae-4d4e-b9ca-f782a1597fd3Product name220210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90cProduct name420200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6dProduct name120190618
aea4a616-4dfe-45f6-94bb-8b9063056cebProduct name620190611
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1Product name120180821
5a6c788d-375b-4565-a8ae-67c179a30c93Product name120180212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1078-3levofloxacin30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1078LEVOFLOXACIN TABLET, FILM COATED [COUPLER LLC]1Current NDC, 1 package rows20250131_2cee61b7-be51-0fe5-e063-6294a90af9e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN2cee61b7-be51-0fe5-e063-6294a90af9e31
199884levofloxacin 250 MG Oral TabletSCD2cee61b7-be51-0fe5-e063-6294a90af9e31
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY2cee61b7-be51-0fe5-e063-6294a90af9e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1078-36704610780330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1078-3) 2025-01-30NoNoCurrent