Home NDC 70756-638 Moxifloxacin ophthalmic solution
Product NDC 70756-638
11-digit product format 707560638
Labeler code 70756
Product ID 70756-638_22d5cd84-26c0-49b0-afbf-1e9155749cf6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Moxifloxacin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Lifestar Pharma LLC
Application ANDA217988
Marketing category ANDA
Marketing start 2025-01-27
Substance MOXIFLOXACIN HYDROCHLORIDE
Active strength 5 mg/mL
Pharmacologic classes Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217988-001 MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217988-001 AT1
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 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 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217988-001 MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 2025-01-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Moxifloxacin ophthalmic solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C53598599T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403818 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 70756-638-25 Moxifloxacin ophthalmic solution 3 mL in 1 BOTTLE SOLUTION/ DROPS 3 4 70756-638-25 Moxifloxacin ophthalmic solution 1 in 1 CARTON SOLUTION/ DROPS 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70756-638 MOXIFLOXACIN OPHTHALMIC SOLUTION (MOXIFLOXACIN) SOLUTION/ DROPS [LIFESTAR PHARMA LLC] 4 Current NDC, 2 package rows 20250204_ca19b837-8e80-408f-af7b-b0464f20c0c3.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70756-638-25 70756063825 1 BOTTLE in 1 CARTON (70756-638-25) / 3 mL in 1 BOTTLE 1 bottle 2025-01-27 No No Current