Prescription drug · ANDA
Neomycin Sulfate NDC 62135-443
Neomycin sulfate 500 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-443-90 | 62135044390 | 90 TABLET in 1 BOTTLE (62135-443-90)Marketed from Nov 27, 2023 |
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 Sulfate
- Generic name (nonproprietary)
- neomycin sulfate
- Active ingredients
- Neomycin sulfate — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204435
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 62135-443_4bd236cf-36cb-c633-e063-6294a90a5b16SPL ID 4bd236cf-36cb-c633-e063-6294a90a5b16SPL set ID 0aa6947b-4739-4b00-be93-7303a5fc687dRxCUI 866042UNII 057Y626693UPC 0362135443900
- Pharmacologic class
- Aminoglycoside 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N462135044390followed by a unit qualifier and the quantityPackage 62135-0443-90. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets and other antibacterial drugs, neomycin sulfate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Suppression of Intestinal Bacteria Neomycin sulfate tablets are indicated as adjunctive therapy as part of a regimen for …
Excerpt only. Read the full label for complete information.
About NDC 62135-443
- What is NDC 62135-443?
- 62135-443 is the product NDC for Neomycin Sulfate, Neomycin sulfate 500 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Neomycin Sulfate.
- What is the active ingredient?
- Neomycin sulfate.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. 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 Sulfate?
- 5 other product NDCs are listed under this name. See all Neomycin Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Neomycin Sulfate 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 Sulfate | Neomycin sulfate 100 kg/100kg | GranuleTopical | Shaanxi Shuvita Biotech Co., Ltd | 87879-003 | 87879-0003-01 |
| Neomycin Sulfate | Neomycin sulfate 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4624 | 70518-4624-00 |
| Neomycin Sulfate | Neomycin sulfate 5 mg/100g | OintmentTopical | Aldermed Inc. | 87236-017 | 87236-0017-09 |
| Neomycin Sulfate | Neomycin sulfate 500 mg/1 | TabletOral | Solaris Pharma Corporation | 73473-901 | 73473-0901-05 |
| Neomycin Sulfate | Neomycin sulfate 500 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-1177 | 00093-1177-01 |