Ofloxacin

Product NDC
55111-161
11-digit product format
551110161
Labeler code
55111
Product ID
55111-161_889d4bcc-0b25-f208-dea4-aedf75197224
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ofloxacin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA077098
Marketing category
ANDA
Marketing start
2006-02-10
Marketing end
0000-00-00
Substance
OFLOXACIN
Active strength
300 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55111-161DDiscontinued by firm2026-08-11
excluded packagepackage55111-16155111-161-01DDiscontinued by firm2026-08-11
excluded packagepackage55111-16155111-161-05DDiscontinued by firm2026-08-11
excluded packagepackage55111-16155111-161-30DDiscontinued by firm2026-08-11
excluded packagepackage55111-16155111-161-50DDiscontinued by firm2026-08-11
excluded packagepackage55111-16155111-161-78DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55111-161-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55111-161-78d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55111-161-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55111-161-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55111-161-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55111-161-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55111-161-78f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55111-161-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55111-161-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55111-161-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55111-161-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55111-161-782ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55111-161-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55111-161-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55111-161-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55111-161-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55111-161-78a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55111-161-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55111-161-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55111-161-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55111-161-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55111-161-78cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55111-161-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55111-161-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55111-161-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55111-161-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55111-161-78cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55111-161-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55111-161-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55111-161-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55111-161-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55111-161-78302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55111-161-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55111-161-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55111-161-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55111-161-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55111-161-78ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55111-161-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55111-161-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55111-161-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55111-161-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55111-161-780efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55111-161-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55111-161-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55111-161-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55111-161-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55111-161-78ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55111-161-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55111-161-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55111-161-50ad56d346431e…cc804d4bbf1e…

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
A077098-001OFLOXACINOFLOXACIN200MGTABLET / ORALAB2006-02-10
A077098-002OFLOXACINOFLOXACIN300MGTABLET / ORALAB2006-02-10
A077098-003OFLOXACINOFLOXACIN400MGTABLET / ORALAB2006-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077098-001AB
A077098-002AB
A077098-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077098-002OFLOXACIN300MGTABLET / ORALAB2006-02-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077098-003OFLOXACIN400MGTABLET / ORALAB2006-02-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077098-001OFLOXACIN200MGTABLET / ORALAB2006-02-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077098-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077098-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077098-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077098-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077098-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077098-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077098-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077098-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077098-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077098-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077098-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077098-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077098-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077098-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077098-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077098-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077098-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077098-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077098-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077098-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077098-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077098-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077098-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077098-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077098-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077098-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077098-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077098-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077098-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077098-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077098-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077098-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077098-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077098-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077098-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077098-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077098-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077098-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077098-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077098-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-161-50EA - Each55111-161ba2e60a4-aef6-4f9d-981c-6290548fae7812012-07-24

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-161-0155111016101100 TABLET, COATED in 1 BOTTLE (55111-161-01) 2006-02-100000-00-00NoNoCurrent
55111-161-0555111016105500 TABLET, COATED in 1 BOTTLE (55111-161-05) 2006-02-100000-00-00NoNoCurrent
55111-161-305511101613030 TABLET, COATED in 1 BOTTLE (55111-161-30) 2006-02-100000-00-00NoNoCurrent
55111-161-505511101615050 TABLET, COATED in 1 BOTTLE (55111-161-50) 2006-02-100000-00-00NoNoCurrent
55111-161-785511101617810 BLISTER PACK in 1 CARTON (55111-161-78) > 10 TABLET, COATED in 1 BLISTER PACK (55111-161-79) 10 blister pack2006-02-100000-00-00NoNoCurrent