Home NDC 69918-515-05 neomycin sulfate, polymyxin b sulfate and dexamethasone
Product NDC 69918-515
Requested package NDC 69918-515-05
11-digit product format 699180515
Labeler code 69918
Product ID 69918-515_34028664-7112-42b9-b6fc-5ed048759680
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name neomycin sulfate, polymyxin b sulfate and dexamethasone
Dosage form SUSPENSION
Route OPHTHALMIC
Labeler Nordic Pharma, Inc.
Application NDA050023
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2025-03-31
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N050023-002 MAXITROL DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS / OPHTHALMIC AT RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050023-002 AT
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N050023-002 MAXITROL 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS / OPHTHALMIC AT RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050023-002 MAXITROL 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS / OPHTHALMIC AT RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050023-002 MAXITROL 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS / OPHTHALMIC AT RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050023-002 MAXITROL 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS / OPHTHALMIC AT RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base neomycin sulfate, polymyxin b sulfate and dexamethasone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEOMYCIN SULFATE 3.5 mg/mL POLYMYXIN B SULFATE 10000 [USP'U]/mL DEXAMETHASONE 1 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69918-515-05 neomycin sulfate, polymyxin b sulfate and dexamethasone 5 mL in 1 BOTTLE, PLASTIC SUSPENSION 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69918-515 NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION [NORDIC PHARMA, INC.] 1 Current NDC, 1 package rows 20250331_191c1a56-194f-4876-b501-2f8aee447d83.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Maxitrol NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE Harrow Eye, LLC ecfb954f-5554-0ad2-e053-2995a90a7516 2025-10-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 050023 application number: NDA050023
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69918-515-05 69918051505 5 mL in 1 BOTTLE, PLASTIC (69918-515-05) 5 ml 2025-03-31 No No Current