Prescription drug · ANDA
Tobramycin And Dexamethasone NDC 0574-4031
Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL · Suspension/ drops · Ophthalmic · Padagis US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0574-4031-05 | 0057440310500574403105 | 1 BOTTLE, PLASTIC in 1 CARTON (0574-4031-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from Mar 17, 2022 | |
| 0574-4031-10 | 0057440311000574403110 | 1 BOTTLE, PLASTIC in 1 CARTON (0574-4031-10) / 10 mL in 1 BOTTLE, PLASTICMarketed from Mar 17, 2022 | |
| 0574-4031-25 | 0057440312500574403125 | 1 BOTTLE, PLASTIC in 1 CARTON (0574-4031-25) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Mar 17, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Padagis US LLCNDC labeler code 0574
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212715
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0574-4031_e51608aa-acc7-4981-862f-4ab1ef89ea9bSPL ID e51608aa-acc7-4981-862f-4ab1ef89ea9bSPL set ID 7e34b1a9-8d21-41db-9070-37227975414fRxCUI 309683UNII 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
N400574403105followed by a unit qualifier and the quantityPackage 00574-4031-05. 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 .
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 bodi…
Excerpt only. Read the full label for complete information.
About NDC 0574-4031
- What is NDC 0574-4031?
- 0574-4031 is the product NDC for Tobramycin And Dexamethasone, Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL suspension/ drops, listed with the FDA by Padagis US LLC. 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?
- Padagis US LLC, NDC labeler code 0574. 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 | 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 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Redpharm Drug | 67296-2174 | 67296-2174-05 |
Other NDCs under ANDA 212715
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 | Bryant Ranch Prepack | 72162-1128 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Bryant Ranch Prepack | 71335-2840 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Bryant Ranch Prepack | 71335-2854 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Redpharm Drug | 67296-2174 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-8046 |
| Tobramycin and dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0260 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Bryant Ranch Prepack | 71335-2891 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-7267 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Bryant Ranch Prepack | 63629-9572 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Bryant Ranch Prepack | 63629-9570 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Bryant Ranch Prepack | 63629-9571 |