Prescription drug · ANDA
Ampicillin (ampicillin sodium) NDC 72603-454
Ampicillin sodium 2 g/1 · Injection, Powder, For solution · Intramuscular, Intravenous · NorthStar Rx, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-454-10 | 72603045410 | 10 VIAL in 1 CARTON (72603-454-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72603-454-01)Marketed from Mar 1, 2024 |
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)
- Ampicillin
- Generic name (nonproprietary)
- ampicillin sodium
- Active ingredients
- Ampicillin sodium — 2 g/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- NorthStar Rx, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062797
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 72603-454_ccfb8b44-c373-40a6-8fc9-afd9584e5970SPL ID ccfb8b44-c373-40a6-8fc9-afd9584e5970SPL set ID 6772d650-9814-49e4-a4ec-0b1a97b837d1RxCUI 1721474, 1721475, 1721476UNII JFN36L5S8KUPC 0372603363012, 0372603221015, 0372603454017
- 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
N472603045410followed by a unit qualifier and the quantityPackage 72603-0454-10. 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 Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by Streptococcus pneumoniae , Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae , and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli , Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes , N. meningitidis ). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organ…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062797
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 |
|---|---|---|---|---|
| Ampicillin | Ampicillin sodium 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Civica, Inc. | 72572-017 |
| Ampicillinampicillin sodium | Ampicillin sodium 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 65219-020 |