Prescription drug · ANDA
Neomycin and Polymyxin B Sulfates and Dexamethasone NDC 61314-630
neomycin sulfate, polymyxin b sulfate and dexamethasone · Neomycin sulfate 3.5 mg/mL + 2 more ingredients · Suspension · Ophthalmic · Sandoz Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-630-06 | 6131406300661314063006 | 5 mL in 1 BOTTLE, PLASTIC (61314-630-06)Marketed from Feb 21, 1996 |
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)
- Neomycin and Polymyxin B Sulfates and Dexamethasone
- Generic name (nonproprietary)
- neomycin sulfate, polymyxin b sulfate and dexamethasone
- Active ingredients
- Neomycin sulfate — 3.5 mg/mLPolymyxin b sulfate — 10000 [USP'U]/mLDexamethasone — 1 mg/mL
- Dosage form
- Suspension
- Route
- Ophthalmic
- Labeler
- Sandoz Inc.NDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062341
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 61314-630_a2bce951-7394-4d72-a7af-7a6c9de35d7eSPL ID a2bce951-7394-4d72-a7af-7a6c9de35d7eSPL set ID cf1a6da8-ba79-4bff-a13b-6effb67f6c1cRxCUI 309680UNII 057Y626693, 19371312D4, 7S5I7G3JQL
- Pharmacologic class
- Aminoglycoside Antibacterial; Corticosteroid; Polymyxin-class Antibacterial
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
N461314063006followed by a unit qualifier and the quantityPackage 61314-0630-06. 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 For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivides 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 an anti-infective component is indicat…
Excerpt only. Read the full label for complete information.
About NDC 61314-630
- What is NDC 61314-630?
- 61314-630 is the product NDC for Neomycin and Polymyxin B Sulfates and Dexamethasone, Neomycin sulfate 3.5 mg/mL + 2 more ingredients suspension, listed with the FDA by Sandoz Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Neomycin and Polymyxin B Sulfates and Dexamethasone (Neomycin sulfate, polymyxin b sulfate and dexamethasone).
- What is the active ingredient?
- Neomycin sulfate, Polymyxin b sulfate, 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 Neomycin and Polymyxin B Sulfates and Dexamethasone?
- 12 other product NDCs are listed under this name. See all Neomycin and Polymyxin B Sulfates 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 Neomycin and Polymyxin B Sulfates 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) |
|---|---|---|---|---|---|
| Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Preferred Pharmaceuticals Inc. | 68788-8748 | 68788-8748-03 |
| Neomycin And Polymyxin B Sulfates And Dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0229 | 80425-0229-01 |
| Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin, polymyxin b sulfates, dexamethasone | Dexamethasone 1 mg/g + 2 more ingredients | OintmentOphthalmic | Proficient Rx LP | 63187-395 | 63187-0395-35 |
| Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | A-S Medication Solutions | 50090-4435 | 50090-4435-00 |
| Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Sandoz Inc | 61314-631 | 61314-0631-36 |
| Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SuspensionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-3359 | 68071-3359-05 |
| Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-5281 | 68071-5281-03 |
| Neomycin and Polymyxin B Sulfates and Dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Proficient Rx LP | 71205-330 | 71205-0330-35 |
| Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | Bausch & Lomb Incorporated | 24208-795 | 24208-0795-35 |
| Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasone | Neomycin sulfate 3.5 mg/g + 2 more ingredients | OintmentOphthalmic | A-S Medication Solutions | 50090-6181 | 50090-6181-00 |
All 13 Neomycin and Polymyxin B Sulfates and Dexamethasone NDCs
Other NDCs under ANDA 062341
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 |
|---|---|---|---|---|
| Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SuspensionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-3359 |