Prescription drug · ANDA
Dicloxacillin Sodium NDC 63629-4256
Dicloxacillin sodium 500 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-4256-1 | 63629425601 | 20 CAPSULE in 1 BOTTLE (63629-4256-1)Marketed from Aug 17, 2022 |
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)
- Dicloxacillin Sodium
- Generic name (nonproprietary)
- dicloxacillin sodium
- Active ingredients
- Dicloxacillin sodium — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 63629-4256_d27a4909-ffaf-4786-b02c-faa01fa80f24SPL ID d27a4909-ffaf-4786-b02c-faa01fa80f24SPL set ID 3e4842ec-773b-4aeb-b37d-1c4e3cf53424RxCUI 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
N463629425601followed by a unit qualifier and the quantityPackage 63629-4256-01. 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 | Teva Pharmaceuticals USA, Inc. | 0093-3125 |
| 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 | Asclemed USA, Inc. | 76420-183 |