What is NDC 46708-518?

46708-518 is the product NDC for Tobramycin Ophthalmic Solution, Tobramycin 3 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tobramycin Ophthalmic Solution?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tobramycin Ophthalmic Solution NDC 46708-518

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-518Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0518Add 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
46708-518-05	4670805180546708051805	1 BOTTLE in 1 CARTON (46708-518-05) / 5 mL in 1 BOTTLEMarketed from Apr 19, 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): Tobramycin Ophthalmic Solution
Generic name (nonproprietary): tobramycin ophthalmic solution
Active ingredients: Tobramycin — 3 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211847
Marketing start: Apr 19, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 46708-518_14c14f81-6b0a-4176-a5df-d0757cc3260dSPL ID 14c14f81-6b0a-4176-a5df-d0757cc3260dSPL set ID 14c14f81-6b0a-4176-a5df-d0757cc3260dRxCUI 313415UNII VZ8RRZ51VK
Pharmacologic class: Aminoglycoside 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

N446708051805 followed by a unit qualifier and the quantity

Package 46708-0518-05. 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 14, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tobramycin ophthalmic solution, 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution. Clinical studies have shown tobramycin to be safe and effective for use in children.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-518

What is NDC 46708-518?: 46708-518 is the product NDC for Tobramycin Ophthalmic Solution, Tobramycin 3 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tobramycin Ophthalmic Solution.
What is the active ingredient?: Tobramycin.
Who is the labeler?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tobramycin Ophthalmic Solution?: 1 other product NDC are listed under this name. See all Tobramycin Ophthalmic Solution 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 Tobramycin Ophthalmic Solution NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tobramycin Ophthalmic Solution	Tobramycin 3 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-518	62332-0518-05

Other NDCs under ANDA 211847

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

FDA NDC Directory listings under ANDA 211847
Product	Strength	Form · route	Labeler	Product NDC
Tobramycin Ophthalmic Solution	Tobramycin 3 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-518