Prescription drug · ANDA
Dicloxacillin Sodium NDC 59651-565
Dicloxacillin sodium 250 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-565-01 | 59651056501 | 100 CAPSULE in 1 BOTTLE (59651-565-01)Marketed from Sep 23, 2022 |
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)
- Dicloxacillin Sodium
- Generic name (nonproprietary)
- dicloxacillin sodium
- Active ingredients
- Dicloxacillin sodium — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216845
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 59651-565_faee6e2d-1b9c-4121-bc22-41313539b366SPL ID faee6e2d-1b9c-4121-bc22-41313539b366SPL set ID 9074b5a6-850c-4144-9097-bb21073ee54dRxCUI 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
N459651056501followed by a unit qualifier and the quantityPackage 59651-0565-01. 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 sodium capsules are indicated in the treatment of infections caused by penicillinase-producing st…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216845
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 500 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-566 |
| Dicloxacillin Sodium | Dicloxacillin sodium 500 mg/1 | CapsuleOral | Redpharm Drug | 67296-2307 |