What is NDC 0078-0771?

0078-0771 is the product NDC for Maxitrol, Neomycin sulfate 3.5 mg/g + 2 more ingredients ointment, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Maxitrol (Neomycin sulfate, polymyxin b sulfate and dexamethasone).

What is the active ingredient?

Neomycin sulfate, Polymyxin b sulfate, Dexamethasone.

Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Maxitrol?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Maxitrol NDC 0078-0771 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0771Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0771Add 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
0078-0771-01	0007807710100078077101	3.5 g in 1 TUBE (0078-0771-01)Marketed from Aug 25, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Maxitrol
Generic name (nonproprietary): neomycin sulfate, polymyxin b sulfate 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: Novartis Pharmaceuticals CorporationNDC labeler code 0078
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050065
Marketing start: Jan 17, 1972
Marketing end: Feb 28, 2027
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
Identifiers: Product ID 0078-0771_6328676b-98d9-4548-bc41-117e0e21eba6SPL ID 6328676b-98d9-4548-bc41-117e0e21eba6SPL set ID 22c6d2db-85af-4a3b-a014-80d901a86717RxCUI 208601, 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

N400078077101 followed by a unit qualifier and the quantity

Package 00078-0771-01. 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 Jun 27, 2023.

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)

About NDC 0078-0771

What is NDC 0078-0771?: 0078-0771 is the product NDC for Maxitrol, Neomycin sulfate 3.5 mg/g + 2 more ingredients ointment, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Maxitrol (Neomycin sulfate, polymyxin b sulfate and dexamethasone).
What is the active ingredient?: Neomycin sulfate, Polymyxin b sulfate, Dexamethasone.
Who is the labeler?: Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Maxitrol?: 2 other product NDCs are listed under this name. See all Maxitrol NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Maxitrol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Maxitrolneomycin sulfate, polymyxin b sulfate and dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	Sandoz Inc	66758-070	66758-0070-38
Maxitrolneomycin sulfate, polymyxin b sulfate and dexamethasone	Neomycin sulfate 3.5 mg/mL + 2 more ingredients	SuspensionOphthalmic	Harrow Eye, LLC	82667-100	82667-0100-05

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
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	A-S Medication Solutions	50090-4435
Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	Sandoz Inc	61314-631
Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	NuCare Pharmaceuticals,Inc.	68071-5281
Neomycin and Polymyxin B Sulfates and Dexamethasone	Neomycin sulfate 3.5 mg/g + 2 more ingredients	OintmentOphthalmic	Proficient Rx LP	71205-330