NDC 61314-631

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-631Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0631Add 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
61314-631-36	61314063136	3.5 g in 1 TUBE (61314-631-36)Marketed from Feb 21, 1996

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 [iU]/gDexamethasone — 1 mg/g
Dosage form: Ointment
Route: Ophthalmic
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 050065
Marketing start: Feb 21, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
Identifiers: Product ID 61314-631_247c1988-9ae8-4e3c-80a0-7d88545fe6b3SPL ID 247c1988-9ae8-4e3c-80a0-7d88545fe6b3SPL set ID 7f2e3c46-9f39-45e7-99a9-64cc4f6f649dRxCUI 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

N461314063136 followed by a unit qualifier and the quantity

Package 61314-0631-36. 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 Oct 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 NDA 050065

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

FDA NDC Directory listings under NDA 050065
Product	Strength	Form · route	Labeler	Product NDC
Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	A-S Medication Solutions	50090-4435
Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	Proficient Rx LP	71205-330
Maxitrolneomycin sulfate, polymyxin b sulfate and dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	Sandoz Inc	66758-070
Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	NuCare Pharmaceuticals,Inc.	68071-5281
Maxitrolneomycin sulfate, polymyxin b sulfate and dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	Novartis Pharmaceuticals Corporation	0078-0771

Neomycin and Polymyxin B Sulfates and Dexamethasone NDC 61314-631