Prescription drug · ANDA
Nafcillin (Nafcillin sodium) NDC 63323-327
Nafcillin sodium 1 g/4mL · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-327-10 | 6332303271063323032710 | 10 VIAL in 1 CARTON (63323-327-10) / 4 mL in 1 VIAL (63323-327-21)Marketed from Jun 30, 2011 |
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)
- Nafcillin
- Generic name (nonproprietary)
- nafcillin sodium
- Active ingredients
- Nafcillin sodium — 1 g/4mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090002
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 63323-327_89168d2d-2dc0-3f50-e053-2a95a90a31beSPL ID 89168d2d-2dc0-3f50-e053-2a95a90a31beSPL set ID c39721a3-7b22-4720-9dbd-bc82f03d2af7RxCUI 1721458, 1721460UNII 49G3001BCK
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463323032710followed by a unit qualifier and the quantityPackage 63323-0327-10. 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: Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY , Susceptibility Testing ). Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to a methicillin-resistant Staphylococcus sp., therapy with Nafcillin for Injection should be discontinued and alternative therapy provided. To reduce the development of drug-resi…
Excerpt only. Read the full label for complete information.
About NDC 63323-327
- What is NDC 63323-327?
- 63323-327 is the product NDC for Nafcillin (nafcillin sodium), Nafcillin sodium 1 g/4mL injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nafcillin (Nafcillin sodium).
- What is the active ingredient?
- Nafcillin sodium.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nafcillin?
- 16 other product NDCs are listed under this name. See all Nafcillin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nafcillin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nafcillin | Nafcillin sodium 10 g/1 | Injection, Powder, For solutionIntravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-316 | 83270-0316-10 |
| Nafcillinnafcillin sodium | Nafcillin sodium 10 g/100mL | Injection, Powder, For solutionIntravenous | Sagent Pharmaceuticals | 25021-198 | 25021-0198-99 |
| Nafcillinnafcillin sodium | Nafcillin sodium 10 g/100mL | Injection, Powder, For solutionIntravenous | Avenacy Inc. | 83634-101 | 83634-0101-99 |
| Nafcillinnafcillin sodium | Nafcillin sodium 1 g/4mL | Injection, Powder, For solutionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc. | 23155-906 | 23155-0906-41 |
| Nafcillinnafcillin sodium | Nafcillin sodium 2 g/8mL | Injection, Powder, For solutionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc. | 23155-907 | 23155-0907-41 |
| Nafcillinnafcillin sodium | Nafcillin sodium 2 g/8mL | Injection, Powder, For solutionIntramuscular, Intravenous | NorthStar Rx, LLC | 72603-453 | 72603-0453-0172603-0453-10 |
| Nafcillin | Nafcillin sodium 10 g/100mL | Injection, Powder, For solutionIntravenous | NorthStar Rx, LLC | 72603-567 | 72603-0567-01 |
| Nafcillin | Nafcillin sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-221 | 44567-0221-10 |
| Nafcillin | Nafcillin sodium 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-222 | 44567-0222-10 |
| Nafcillinnafcillin sodium | Nafcillin sodium 1 g/4mL | Injection, Powder, For solutionIntramuscular, Intravenous | Eugia US LLC | 55150-122 | 55150-0122-15 |
Other NDCs under ANDA 090002
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 |
|---|---|---|---|---|
| Nafcillinnafcillin sodium | Nafcillin sodium 2 g/8mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-328 |
| Nafcillinnafcillin sodium | Nafcillin sodium 2 g/8mL | Injection, Powder, For solutionIntramuscular, Intravenous | NorthStar Rx, LLC | 72603-453 |