Home NDC 68083-394 LEVOFLOXACIN
Product NDC 68083-394
11-digit product format 680830394
Labeler code 68083
Product ID 68083-394_949f1c99-7067-450e-bc22-504f5aed0de9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVOFLOXACIN
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA205540
Marketing category ANDA
Marketing start 2020-04-22
Substance LEVOFLOXACIN
Active strength 25 mg/mL
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205540-001 LEVOFLOXACIN LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 A205540-002 LEVOFLOXACIN LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 76 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 2026-08-18 06:07:40 2026-07 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205540-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205540-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2020-04-22 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base LEVOFLOXACIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOFLOXACIN 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6GNT3Y5LMF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665517 Internal RxNorm lookup 1665519 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68083-394-01 LEVOFLOXACIN 1 in 1 CARTON INJECTION, SOLUTION 1 5 68083-394-01 LEVOFLOXACIN 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-394 LEVOFLOXACIN INJECTION, SOLUTION [GLAND PHARMA LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20240910_ba69722b-d7f2-4519-8a63-9ee91294c499.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68083-394-01 68083039401 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-394-01) / 20 mL in 1 VIAL, SINGLE-DOSE 2020-04-22 0000-00-00 No No Current