Prescription drug · ANDA
Neomycin and Polymyxin B Sulfates and Dexamethasone NDC 68071-3359
neomycin sulfate, polymyxin b sulfate and dexamethasone · Neomycin sulfate 3.5 mg/mL + 2 more ingredients · Suspension · Ophthalmic · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3359-5 | 6807133590568071335905 | 5 mL in 1 BOX (68071-3359-5)Marketed from Jul 21, 2017 |
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)
- 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
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- 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 68071-3359_1ce915c3-50fd-c89b-e063-6294a90a1d0eSPL ID 1ce915c3-50fd-c89b-e063-6294a90a1d0eSPL set ID 54da7bef-c3b0-4353-e054-00144ff8d46cRxCUI 309680UNII 057Y626693, 19371312D4, 7S5I7G3JQLUPC 0368071335958
- 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
N468071335905followed by a unit qualifier and the quantityPackage 68071-3359-05. 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 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 papebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids 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 an anti-infective component is indica…
Excerpt only. Read the full label for complete information.
About NDC 68071-3359
- What is NDC 68071-3359?
- 68071-3359 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 NuCare Pharmaceuticals,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?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | SuspensionOphthalmic | Sandoz Inc. | 61314-630 | 61314-0630-06 |
| 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 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 | Sandoz Inc. | 61314-630 |