Prescription drug · NDA AUTHORIZED GENERIC
Tobramycin and Dexamethasone NDC 61314-647
Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL · Suspension/ drops · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-647-05 | 6131406470561314064705 | 1 BOTTLE in 1 CARTON (61314-647-05) / 5 mL in 1 BOTTLEMarketed from Jan 2, 2015 | |
| 61314-647-10 | 6131406471061314064710 | 1 BOTTLE in 1 CARTON (61314-647-10) / 10 mL in 1 BOTTLEMarketed from Jan 2, 2009 | |
| 61314-647-25 | 6131406472561314064725 | 1 BOTTLE in 1 CARTON (61314-647-25) / 2.5 mL in 1 BOTTLEMarketed from Jan 2, 2009 |
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 and Dexamethasone
- Generic name (nonproprietary)
- tobramycin and dexamethasone
- Active ingredients
- Tobramycin — 3 mg/mLDexamethasone — 1 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Sandoz IncNDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 050592
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 61314-647_31092e87-b110-463c-a306-679c094ab7a7SPL ID 31092e87-b110-463c-a306-679c094ab7a7
- 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
N461314064705followed by a unit qualifier and the quantityPackage 61314-0647-05. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 61314-647
- What is NDC 61314-647?
- 61314-647 is the product NDC for Tobramycin and Dexamethasone, Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL suspension/ drops, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tobramycin and Dexamethasone.
- What is the active ingredient?
- Tobramycin, Dexamethasone.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 61314. 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 and Dexamethasone?
- 23 other product NDCs are listed under this name. See all Tobramycin and Dexamethasone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tobramycin and Dexamethasone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tobramycin and Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Preferred Pharmaceuticals Inc. | 68788-4081 | 68788-4081-05 |
| Tobramycin and Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | REMEDYREPACK INC. | 70518-3994 | 70518-3994-00 |
| Tobramycin and Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Advanced Rx of Tennessee, LLC | 80425-0366 | 80425-0366-01 |
| Tobramycin and dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0260 | 80425-0260-01 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Padagis US LLC | 0574-4031 | 00574-4031-0500574-4031-1000574-4031-25 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-7267 | 50090-7267-00 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-8046 | 50090-8046-00 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Bryant Ranch Prepack | 63629-9570 | 63629-9570-01 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Bryant Ranch Prepack | 63629-9571 | 63629-9571-01 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Bryant Ranch Prepack | 63629-9572 | 63629-9572-01 |
Other NDCs under NDA 050592
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 |
|---|---|---|---|---|
| Tobramycin and Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-1135 |
| Tobramycin and Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-1136 |
| Tobramycin and Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Preferred Pharmaceuticals Inc. | 68788-4081 |
| Tobramycin and Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | REMEDYREPACK INC. | 70518-3994 |
| Tobramycin and Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Advanced Rx of Tennessee, LLC | 80425-0366 |