Prescription drug · ANDA
Neomycin Sulfate NDC 0093-1177
Neomycin sulfate 500 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-1177-01 | 00093117701 | 100 TABLET in 1 BOTTLE (0093-1177-01)Marketed from Sep 30, 1990 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 060304
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 0093-1177_18e9e5b7-e08c-445e-86bb-90bc0953eda9SPL ID 18e9e5b7-e08c-445e-86bb-90bc0953eda9SPL set ID 777dbfab-f83e-4738-ae1e-78619a9f82a7RxCUI 866042UNII 057Y626693UPC 0300931177018
- 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
N400093117701followed by a unit qualifier and the quantityPackage 00093-1177-01. 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 . 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, USP and other antibacterial drugs, neomycin sulfate tablets, USP 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 re…
Excerpt only. Read the full label for complete information.
About NDC 0093-1177
- What is NDC 0093-1177?
- 0093-1177 is the product NDC for Neomycin Sulfate, Neomycin sulfate 500 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. 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?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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 | Chartwell RX, LLC | 62135-443 | 62135-0443-90 |
Other NDCs under ANDA 060304
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 Sulfate | Neomycin sulfate 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4624 |