Home NDC 55111-162 Ofloxacin
Product NDC 55111-162
11-digit product format 551110162
Labeler code 55111
Product ID 55111-162_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 400 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
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.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077098-001 OFLOXACIN OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 A077098-002 OFLOXACIN OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 A077098-003 OFLOXACIN OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077098-002 OFLOXACIN 300MG TABLET / ORAL AB 2006-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077098-003 OFLOXACIN 400MG TABLET / ORAL AB 2006-02-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077098-001 OFLOXACIN 200MG TABLET / ORAL AB 2006-02-10 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ofloxacin ACTIVE INGREDIENT A4P49JAZ9H OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4 ofloxacin ACTIVE MOIETY A4P49JAZ9H OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4 colloidal silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4 HYPROMELLOSE 2910 (5 CPS) INACTIVE INGREDIENT R75537T0T4 OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55111-162-01 55111016201 100 TABLET, COATED in 1 BOTTLE (55111-162-01) 2006-02-10 0000-00-00 No No Current 55111-162-05 55111016205 500 TABLET, COATED in 1 BOTTLE (55111-162-05) 2006-02-10 0000-00-00 No No Current 55111-162-30 55111016230 30 TABLET, COATED in 1 BOTTLE (55111-162-30) 2006-02-10 0000-00-00 No No Current 55111-162-50 55111016250 50 TABLET, COATED in 1 BOTTLE (55111-162-50) 2006-02-10 0000-00-00 No No Current 55111-162-78 55111016278 10 BLISTER PACK in 1 CARTON (55111-162-78) > 10 TABLET, COATED in 1 BLISTER PACK (55111-162-79) 10 blister pack 2006-02-10 0000-00-00 No No Current