Prescription drug · NDA
Tobradex ST (Tobramycin / dexamethasone) NDC 71776-035
Tobramycin 3 mg/mL; Dexamethasone .5 mg/mL · Suspension/ drops · Ophthalmic · Eyevance Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71776-035-01 | 7177600350171776003501 | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-01) / 1 mL in 1 BOTTLE, DROPPERMarketed from May 19, 2021 | |
| 71776-035-05 | 7177600350571776003505 | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from May 19, 2021 |
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
- Eyevance Pharmaceuticals, LLCNDC labeler code 71776
- 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 71776-035_2bd6e870-446a-02f4-e063-6394a90a27b0SPL ID 2bd6e870-446a-02f4-e063-6394a90a27b0SPL set ID c2d7325e-4f58-5590-e053-2a95a90ace1bRxCUI 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
N471776003501followed by a unit qualifier and the quantityPackage 71776-0035-01. 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 71776-035
- What is NDC 71776-035?
- 71776-035 is the product NDC for Tobradex ST (tobramycin / dexamethasone), Tobramycin 3 mg/mL; Dexamethasone .5 mg/mL suspension/ drops, listed with the FDA by Eyevance Pharmaceuticals, 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?
- Eyevance Pharmaceuticals, LLC, NDC labeler code 71776. 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 | Harrow Eye, LLC | 82667-011 | 82667-0011-0082667-0011-05 |
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 | Harrow Eye, LLC | 82667-011 |