Prescription drug · ANDA
Neomycin Polymyxin B Sulfates and Dexamethasone NDC 68788-9702
neomycin sulfate, polymyxin b sulfate and dexamethasone · Neomycin sulfate 3.5 mg/mL + 2 more ingredients · Suspension/ drops · Ophthalmic · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-9702-5 | 6878897020568788970205 | 1 BOTTLE, DROPPER in 1 CARTON (68788-9702-5) / 5 mL in 1 BOTTLE, DROPPERMarketed from Mar 14, 2013 |
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 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/ drops
- Route
- Ophthalmic
- Labeler
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064135
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
- Identifiers
- Product ID 68788-9702_e445f9fe-3091-4ff5-af8a-9be502efd245SPL ID e445f9fe-3091-4ff5-af8a-9be502efd245SPL set ID 449a6fd8-c2ac-40d0-b74a-e5c7fc6670f3RxCUI 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
N468788970205followed by a unit qualifier and the quantityPackage 68788-9702-05. 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 palpebral 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 indic…
Excerpt only. Read the full label for complete information.
About NDC 68788-9702
- What is NDC 68788-9702?
- 68788-9702 is the product NDC for Neomycin Polymyxin B Sulfates and Dexamethasone, Neomycin sulfate 3.5 mg/mL + 2 more ingredients suspension/ drops, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Neomycin 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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 Polymyxin B Sulfates and Dexamethasone?
- 5 other product NDCs are listed under this name. See all Neomycin 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 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 Polymyxin B Sulfates And Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsTopical | DirectRx | 72189-320 | 72189-0320-05 |
| Neomycin Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-830 | 24208-0830-60 |
| Neomycin Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-0570 | 50090-0570-00 |
| Neomycin Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | Proficient Rx LP | 63187-498 | 63187-0498-05 |
| Neomycin Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4375 | 68071-4375-05 |
Other NDCs under ANDA 064135
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 Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-830 |
| Neomycin Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | A-S Medication Solutions | 50090-0570 |
| Neomycin Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | Proficient Rx LP | 63187-498 |
| Neomycin Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4375 |
| Neomycin Polymyxin B Sulfates And Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops | Neomycin sulfate 3.5 mg/mL + 2 more ingredients | Suspension/ dropsTopical | DirectRx | 72189-320 |