NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2418Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2418Add 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 NDC11-digit (billing)PackageCopy
68071-2418-2680712418021 BOTTLE, DROPPER in 1 CARTON (68071-2418-2) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from May 26, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 and Dexamethasone
Generic name (nonproprietary)
tobramycin and dexamethasone
Active ingredients
Tobramycin3 mg/mLDexamethasone1 mg/mL
Dosage form
Suspension/ drops
Route
Ophthalmic
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 064134
Marketing start
Listing expires
Other FDA classes
Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 68071-2418_4e061c56-47ec-aed6-e063-6394a90aae59SPL ID 4e061c56-47ec-aed6-e063-6394a90aae59SPL set ID c33e84ba-4c0c-f738-e053-2995a90aa20aRxCUI 309683UNII VZ8RRZ51VK, 7S5I7G3JQLUPC 0368071241822
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 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

N468071241802 followed by a unit qualifier and the quantity

Package 68071-2418-02. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular 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 bodie

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 064134

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

FDA NDC Directory listings under ANDA 064134
ProductStrengthForm · routeLabelerProduct NDC
Tobramycin and DexamethasoneTobramycin 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsOphthalmicBausch & Lomb Incorporated24208-295
Tobramycin and DexamethasoneTobramycin 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsOphthalmicA-S Medication Solutions50090-1914
Tobramycin and DexamethasoneTobramycin 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsOphthalmicNuCare Pharmaceuticals,Inc.68071-4203
Tobramycin and DexamethasoneTobramycin 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsOphthalmicSportpharm LLC85766-188
Tobramycin and DexamethasoneTobramycin 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsOphthalmicSportpharm LLC85766-188
Tobramycin and DexamethasoneTobramycin 3 mg/mL; Dexamethasone 1 mg/mLSuspension/ dropsOphthalmicNuCare Pharmaceuticals,Inc.68071-1821

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