Prescription drug · ANDA
Tobramycin And Dexamethasone NDC 63629-9571
Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL · Suspension/ drops · Ophthalmic · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-9571-1 | 63629957101 | 5 mL in 1 BOTTLE, PLASTIC (63629-9571-1)Marketed from Dec 21, 2022 |
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
- Tobramycin — 3 mg/mLDexamethasone — 1 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Bryant Ranch Prepack
- 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 63629-9571_3f1161dc-5f48-47eb-bb62-802f5f6c9a67SPL ID 3f1161dc-5f48-47eb-bb62-802f5f6c9a67SPL set ID a5f0b05b-3dec-4fe8-8106-e41e668a512dRxCUI 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
N463629957101followed by a unit qualifier and the quantityPackage 63629-9571-01. 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)
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.
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 | 71335-2891 |
| 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 | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0260 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Padagis US LLC | 0574-4031 |
| 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 | Bryant Ranch Prepack | 72162-1128 |
| 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 | 63629-9570 |
| 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 | 71335-2840 |
| Tobramycin And Dexamethasone | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsOphthalmic | Bryant Ranch Prepack | 71335-2854 |