Prescription drug · ANDA
Ampicillin Sodium and Sulbactam Sodium NDC 72485-418
ampicillin sodium, sulbactam sodium · Ampicillin sodium 10 g/15g; Sulbactam sodium 5 g/15g · Injection, Powder, For solution · Intramuscular, Intravenous · Armas Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72485-418-15 | 72485041815 | 1 BOTTLE in 1 CARTON (72485-418-15) / 15 g in 1 BOTTLEMarketed from May 1, 2025 |
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 Sodium and Sulbactam Sodium
- Generic name (nonproprietary)
- ampicillin sodium, sulbactam sodium
- Active ingredients
- Ampicillin sodium — 10 g/15gSulbactam sodium — 5 g/15g
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Armas Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202197
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 72485-418_44e29e92-b036-b2f8-e063-6394a90a7f6aSPL ID 44e29e92-b036-b2f8-e063-6394a90a7f6aSPL set ID 409f8a6d-f54f-415f-994c-ecd2b820caabRxCUI 240984UNII JFN36L5S8K, DKQ4T82YE6
- Pharmacologic class
- Penicillin-class Antibacterial; beta Lactamase Inhibitor
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
N472485041815followed by a unit qualifier and the quantityPackage 72485-0418-15. 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 and Sulbactam for Injection, USP, is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus , Escherichia coli , * Klebsiella spp. * (including K. pneumoniae * ), Proteus mirabilis, * Bacteroides fragilis , * Enterobacter spp ., * and Acinetobacter calcoaceticus . * NOTE: For information on use in pediatric patients (see PRECAUTIONS–Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella sp…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202197
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 Sodium and Sulbactam Sodiumampicillin sodium, sulbactam sodium | Ampicillin sodium 10 g/15g; Sulbactam sodium 5 g/15g | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-308 |