What is NDC 0054-0975?

0054-0975 is the product NDC for Neomycin and Polymyxin B sulfates and Hydrocortisone OTIC, Neomycin sulfate 3.5 mg/mL + 2 more ingredients solution/ drops, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Neomycin and Polymyxin B sulfates and Hydrocortisone OTIC (Neomycin and Polymyxin B sulfates and Hydrocortisone).

What is the active ingredient?

Neomycin sulfate, Polymyxin b sulfate, Hydrocortisone.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Neomycin and Polymyxin B sulfates and Hydrocortisone OTIC?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 0054-0975

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0975Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0975Add 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
0054-0975-80	0005409758000054097580	1 BOTTLE, DROPPER in 1 CARTON (0054-0975-80) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 8, 2026

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): Neomycin and Polymyxin B sulfates and Hydrocortisone OTICSuffix: OTIC
Generic name (nonproprietary): neomycin and polymyxin b sulfates and hydrocortisone
Active ingredients: Neomycin sulfate — 3.5 mg/mLPolymyxin b sulfate — 10000 [iU]/mLHydrocortisone — 10 mg/mL
Dosage form: Solution/ drops
Route: Auricular (Otic)
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220938
Marketing start: Oct 8, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
Identifiers: Product ID 0054-0975_aefabd5a-1362-4384-9ebf-9ee2492f4063SPL ID aefabd5a-1362-4384-9ebf-9ee2492f4063
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400054097580 followed by a unit qualifier and the quantity

Package 00054-0975-80. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0054-0975

What is NDC 0054-0975?: 0054-0975 is the product NDC for Neomycin and Polymyxin B sulfates and Hydrocortisone OTIC, Neomycin sulfate 3.5 mg/mL + 2 more ingredients solution/ drops, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Neomycin and Polymyxin B sulfates and Hydrocortisone OTIC (Neomycin and Polymyxin B sulfates and Hydrocortisone).
What is the active ingredient?: Neomycin sulfate, Polymyxin b sulfate, Hydrocortisone.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Neomycin and Polymyxin B sulfates and Hydrocortisone OTIC?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Neomycin and Polymyxin B sulfates and Hydrocortisone OTIC NDC 0054-0975