Prescription drug · NDA
Tobradex ST (Tobramycin / dexamethasone) NDC 82667-011
Tobramycin 3 mg/mL; Dexamethasone .5 mg/mL · Suspension/ drops · Ophthalmic · Harrow Eye, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82667-011-00 | 8266700110082667001100 | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPERMarketed from Mar 31, 2025 | |
| 82667-011-05 | 8266700110582667001105 | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Mar 31, 2025 |
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)
- Tobradex ST
- Generic name (nonproprietary)
- tobramycin / dexamethasone
- Active ingredients
- Tobramycin — 3 mg/mLDexamethasone — .5 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Harrow Eye, LLCNDC labeler code 82667
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050818
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 82667-011_31ba978f-7bc8-031f-e063-6394a90ae09cSPL ID 31ba978f-7bc8-031f-e063-6394a90ae09cSPL set ID 3b99dbb3-ac84-4d0d-b30f-a5db44fdc316RxCUI 849115, 1011080UNII VZ8RRZ51VK, 7S5I7G3JQL
- 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
N482667001100followed by a unit qualifier and the quantityPackage 82667-0011-00. 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)
TOBRADEX ST 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 bodies. The use of a combination drug with a…
Excerpt only. Read the full label for complete information.
About NDC 82667-011
- What is NDC 82667-011?
- 82667-011 is the product NDC for Tobradex ST (tobramycin / dexamethasone), Tobramycin 3 mg/mL; Dexamethasone .5 mg/mL suspension/ drops, listed with the FDA by Harrow Eye, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tobradex ST (Tobramycin / dexamethasone).
- What is the active ingredient?
- Tobramycin, Dexamethasone.
- Who is the labeler?
- Harrow Eye, LLC, NDC labeler code 82667. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tobradex ST?
- 1 other product NDC are listed under this name. See all Tobradex ST NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tobradex ST products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tobradex STtobramycin / dexamethasone | Tobramycin 3 mg/mL; Dexamethasone .5 mg/mL | Suspension/ dropsOphthalmic | Eyevance Pharmaceuticals, LLC | 71776-035 | 71776-0035-0171776-0035-05 |
Other NDCs under NDA 050818
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tobradex STtobramycin / dexamethasone | Tobramycin 3 mg/mL; Dexamethasone .5 mg/mL | Suspension/ dropsOphthalmic | Eyevance Pharmaceuticals, LLC | 71776-035 |