Prescription drug · ANDA
Dicloxacillin Sodium NDC 0093-3125
Dicloxacillin sodium 500 mg/1 · Capsule · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-3125-01 | 00093312501 | 100 CAPSULE in 1 BOTTLE (0093-3125-01)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)
- Dicloxacillin Sodium
- Generic name (nonproprietary)
- dicloxacillin sodium
- Active ingredients
- Dicloxacillin sodium — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062286
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 0093-3125_1976304d-7c32-40f7-9724-0d1903dad50eSPL ID 1976304d-7c32-40f7-9724-0d1903dad50eSPL set ID 8478f242-c715-4984-ac1d-dc79dc28665eRxCUI 197595, 197596UNII 4HZT2V9KX0
- Pharmacologic class
- Penicillin-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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400093312501followed by a unit qualifier and the quantityPackage 00093-3125-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules 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. Dicloxacillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062286
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 |
|---|---|---|---|---|
| Dicloxacillin Sodium | Dicloxacillin sodium 250 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-180 |
| Dicloxacillin Sodium | Dicloxacillin sodium 250 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-096 |
| Dicloxacillin Sodium | Dicloxacillin sodium 250 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-3123 |
| Dicloxacillin Sodium | Dicloxacillin sodium 500 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-097 |
| Dicloxacillin Sodium | Dicloxacillin sodium 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-473 |
| Dicloxacillin Sodium | Dicloxacillin sodium 250 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 55289-592 |
| Dicloxacillin Sodium | Dicloxacillin sodium 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-4256 |
| Dicloxacillin Sodium | Dicloxacillin sodium 500 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-183 |