Prescription drug · ANDA
Ampicillin and Sulbactam NDC 0641-6116
Ampicillin sodium 1 g/1.5g; Sulbactam sodium .5 g/1.5g · Injection, Powder, For solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6116-10 | 00641611610 | 10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01)Marketed from Dec 22, 2009 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 and Sulbactam
- Generic name (nonproprietary)
- ampicillin and sulbactam
- Active ingredients
- Ampicillin sodium — 1 g/1.5gSulbactam sodium — .5 g/1.5g
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065406
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 0641-6116_dcc2eac1-a1d3-4650-bbbc-5338dea664e4SPL ID dcc2eac1-a1d3-4650-bbbc-5338dea664e4SPL set ID d3026cc0-95d8-44cf-be47-b5ebb8fd4568RxCUI 1659592, 1659598UNII DKQ4T82YE6, JFN36L5S8K
- 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
N400641611610followed by a unit qualifier and the quantityPackage 00641-6116-10. 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 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 spp. (includi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065406
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 and Sulbactamampicillin sodium and sulbactam sodium | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-032 |
| Ampicillin and Sulbactamampicillin sodium and sulbactam sodium | Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-031 |
| Ampicillin and Sulbactamampicillin sodium and sulbactam sodium | Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-031 |
| Ampicillin and Sulbactamampicillin sodium and sulbactam sodium | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-032 |
| Ampicillin and Sulbactam | Ampicillin sodium 2 g/3g; Sulbactam sodium 1 g/3g | Injection, Powder, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6117 |
| ampicillin and sulbactam | Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-142 |
| ampicillin and sulbactam | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-143 |