NDC 80425-0229

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0229Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0229Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
80425-0229-1	80425022901	1 TUBE in 1 CARTON (80425-0229-1) / 3.5 g in 1 TUBEMarketed from Jan 11, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Neomycin And Polymyxin B Sulfates And Dexamethasone
Generic name (nonproprietary): neomycin and polymyxin b sulfates and dexamethasone
Active ingredients: Neomycin sulfate — 3.5 mg/gPolymyxin b sulfate — 10000 [USP'U]/gDexamethasone — 1 mg/g
Dosage form: Ointment
Route: Ophthalmic
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 064063
Marketing start: Jan 11, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
Identifiers: Product ID 80425-0229_2a9b1617-60d0-f8ce-e063-6294a90ab02cSPL ID 2a9b1617-60d0-f8ce-e063-6294a90ab02cSPL set ID f1a05d5f-74f2-17a1-e053-2995a90ab0e7RxCUI 309679UNII 057Y626693, 19371312D4, 7S5I7G3JQL
Pharmacologic class: Aminoglycoside Antibacterial; Corticosteroid; Polymyxin-class Antibacterial

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480425022901 followed by a unit qualifier and the quantity

Package 80425-0229-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 31, 2024.

Indications (excerpt from the label)

Indications and Usage For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated whe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 064063

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 064063
Product	Strength	Form · route	Labeler	Product NDC
Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	Proficient Rx LP	63187-669
Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	Bausch & Lomb Incorporated	24208-795
Neo/Poly-B/Dex Ophth Oint	Polymyxin b sulfate 10000 [USP'U]/g + 2 more ingredients	OintmentOphthalmic	Direct_Rx	72189-532
Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	A-S Medication Solutions	50090-6181
Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	NuCare Pharmaceuticals,Inc.	68071-2428
Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	Preferred Pharmaceuticals Inc.	68788-8748

Neomycin And Polymyxin B Sulfates And Dexamethasone NDC 80425-0229