Ofloxacin

Product NDC
60505-0560
11-digit product format
605050560
Labeler code
60505
Product ID
60505-0560_9fc163d2-e518-3e95-f589-2ad375775998
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Apotex Corp.
Application
ANDA076513
Marketing category
ANDA
Marketing start
2019-03-01
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076513-001OFLOXACINOFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076513-001AT

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-143f01610625f2…
2019-09-15 20:21 UTC2019-09A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076513-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2004-05-14cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076513-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076513-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076513-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076513-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076513-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076513-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076513-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076513-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076513-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076513-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076513-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076513-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076513-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076513-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076513-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076513-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076513-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076513-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076513-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076513-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076513-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A076513-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076513-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076513-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076513-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A076513-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076513-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076513-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076513-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076513-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076513-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076513-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076513-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076513-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076513-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076513-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076513-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076513-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076513-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076513-001AT1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OFLOXACIN3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A4P49JAZ9HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312075Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5117d567-2004-c5ed-1391-f8831864696fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f9d82093-3de1-4841-9a42-67222d61a0cfProduct name420250515
bbed5f06-a6b7-a443-70ac-77518a9524b7Product name720250311
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
41679fed-052c-574b-6b40-cadcbc315b79Product name220150401
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0560-0Ofloxacin1 in 1 CARTONSOLUTION112
60505-0560-0Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION512
60505-0560-1Ofloxacin10 mL in 1 BOTTLE, DROPPERSOLUTION1012
60505-0560-1Ofloxacin1 in 1 CARTONSOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0560-0ML - Milliliter60505-0560bcf5ecdc-ac31-4ba3-ba45-e11e15a6a7f212019-03-12
60505-0560-1ML - Milliliter60505-05601e051de2-1ad0-4fb4-8e1f-794fc1190e3f12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0560OFLOXACIN SOLUTION [APOTEX CORP.]11Current NDC, Legacy NDC, 4 package rows20241105_5117d567-2004-c5ed-1391-f8831864696f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OfloxacinOFLOXACINSt. Mary's Medical Park Pharmacy2d55b26d-9d12-ca29-e063-6294a90ab2372026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076513
application number: ANDA076513
OfloxacinOFLOXACINPreferred Pharmaceuticals Inc.f7916bb3-7593-45f8-b9de-98e0f2d572272026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076513
application number: ANDA076513
OfloxacinOFLOXACINApotex Corp.5117d567-2004-c5ed-1391-f8831864696f2025-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076513
application number: ANDA076513
ndc (product): 60505-0560
OfloxacinOFLOXACINA-S Medication Solutionsab5b0e34-ac5c-4c0c-b104-934b319ae0112025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076513
application number: ANDA076513
OfloxacinOFLOXACINProficient Rx LP5a9de529-6f85-467a-97b0-8ce124c311732024-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076513
application number: ANDA076513
OfloxacinOFLOXACINA-S Medication Solutions392d458f-8815-49f4-9c2b-0e721e295b1f2024-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076513
application number: ANDA076513
OfloxacinOFLOXACINNuCare Pharmceuticals,Inc.102c825b-af5c-42e7-e063-6394a90a81a12024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076513
application number: ANDA076513

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSN5117d567-2004-c5ed-1391-f8831864696f12
312075ofloxacin 0.3 % Ophthalmic SolutionPSNab5b0e34-ac5c-4c0c-b104-934b319ae01112
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD5117d567-2004-c5ed-1391-f8831864696f12
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDab5b0e34-ac5c-4c0c-b104-934b319ae01112
312075ofloxacin 0.3 % Ophthalmic SolutionSY5117d567-2004-c5ed-1391-f8831864696f12
312075ofloxacin 0.3 % Ophthalmic SolutionSYab5b0e34-ac5c-4c0c-b104-934b319ae01112
312075ofloxacin 0.3 % Ophthalmic SolutionPSN392d458f-8815-49f4-9c2b-0e721e295b1f9
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD392d458f-8815-49f4-9c2b-0e721e295b1f9
312075ofloxacin 0.3 % Ophthalmic SolutionSY392d458f-8815-49f4-9c2b-0e721e295b1f9
312075ofloxacin 0.3 % Ophthalmic SolutionPSN5a9de529-6f85-467a-97b0-8ce124c311732
312075ofloxacin 0.3 % Ophthalmic SolutionPSN93a9c5ca-2419-43a7-bea3-977110617cae2
312075ofloxacin 0.3 % Ophthalmic SolutionPSNcd01954d-918b-456a-e053-2995a90a859c2
312075ofloxacin 0.3 % Ophthalmic SolutionPSNf7916bb3-7593-45f8-b9de-98e0f2d572272
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDcd01954d-918b-456a-e053-2995a90a859c2
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDf7916bb3-7593-45f8-b9de-98e0f2d572272
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD93a9c5ca-2419-43a7-bea3-977110617cae2
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD5a9de529-6f85-467a-97b0-8ce124c311732
312075ofloxacin 0.3 % Ophthalmic SolutionSY5a9de529-6f85-467a-97b0-8ce124c311732
312075ofloxacin 0.3 % Ophthalmic SolutionSY93a9c5ca-2419-43a7-bea3-977110617cae2
312075ofloxacin 0.3 % Ophthalmic SolutionSYcd01954d-918b-456a-e053-2995a90a859c2
312075ofloxacin 0.3 % Ophthalmic SolutionSYf7916bb3-7593-45f8-b9de-98e0f2d572272
312075ofloxacin 0.3 % Ophthalmic SolutionPSN4a86ae0b-c644-4cef-9ecf-07ec31590af51
312075ofloxacin 0.3 % Ophthalmic SolutionPSN2d55b26d-9d12-ca29-e063-6294a90ab2371
312075ofloxacin 0.3 % Ophthalmic SolutionPSN102c825b-af5c-42e7-e063-6394a90a81a11
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD4a86ae0b-c644-4cef-9ecf-07ec31590af51
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD2d55b26d-9d12-ca29-e063-6294a90ab2371
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD102c825b-af5c-42e7-e063-6394a90a81a11
312075ofloxacin 0.3 % Ophthalmic SolutionSY102c825b-af5c-42e7-e063-6394a90a81a11
312075ofloxacin 0.3 % Ophthalmic SolutionSY4a86ae0b-c644-4cef-9ecf-07ec31590af51
312075ofloxacin 0.3 % Ophthalmic SolutionSY2d55b26d-9d12-ca29-e063-6294a90ab2371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0560-0605050560001 BOTTLE, DROPPER in 1 CARTON (60505-0560-0) / 5 mL in 1 BOTTLE, DROPPER2019-03-010000-00-00NoNoCurrent
60505-0560-1605050560011 BOTTLE, DROPPER in 1 CARTON (60505-0560-1) / 10 mL in 1 BOTTLE, DROPPER2019-03-010000-00-00NoNoCurrent