What is NDC 63481-529?

63481-529 is the product NDC for Cortisporin TC, Colistin sulfate 3 mg/mL + 3 more ingredients suspension, listed with the FDA by Endo USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Cortisporin TC (Colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate).

What is the active ingredient?

Colistin sulfate, Neomycin sulfate, Thonzonium bromide, Hydrocortisone acetate.

Endo USA, Inc., NDC labeler code 63481. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cortisporin TC?

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.

Cortisporin TC NDC 63481-529 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63481-529Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63481-0529Add 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
63481-529-10	6348105291063481052910	10 mL in 1 BOTTLE, DROPPER (63481-529-10)Marketed from Jun 3, 2019

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): Cortisporin TC
Generic name (nonproprietary): colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate
Active ingredients: Colistin sulfate — 3 mg/mLNeomycin sulfate — 3.3 mg/mLThonzonium bromide — .5 mg/mLHydrocortisone acetate — 10 mg/mL
Dosage form: Suspension
Route: Auricular (Otic)
Labeler: Endo USA, Inc.NDC labeler code 63481
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050356
Marketing start: Jun 3, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 63481-529_ec1e8a16-a5be-4ff7-a8fe-e0cbfd25aea6SPL ID ec1e8a16-a5be-4ff7-a8fe-e0cbfd25aea6SPL set ID 9c6fc1c7-3350-42ae-b999-aca48e704bb1RxCUI 854992, 854997UNII WP15DXU577, 057Y626693, JI2B19CR0R, 3X7931PO74
Pharmacologic class: Aminoglycoside Antibacterial; Corticosteroid

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

N463481052910 followed by a unit qualifier and the quantity

Package 63481-0529-10. 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 Aug 1, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cortisporin ® TC Otic is indicated for the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63481-529

What is NDC 63481-529?: 63481-529 is the product NDC for Cortisporin TC, Colistin sulfate 3 mg/mL + 3 more ingredients suspension, listed with the FDA by Endo USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cortisporin TC (Colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate).
What is the active ingredient?: Colistin sulfate, Neomycin sulfate, Thonzonium bromide, Hydrocortisone acetate.
Who is the labeler?: Endo USA, Inc., NDC labeler code 63481. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cortisporin TC?: 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.