Prescription drug · ANDA
Ampicillin (Ampicillin sodium) NDC 65219-016
Ampicillin sodium 500 mg/1 · Injection, Powder, For solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-016-10 | 6521900161065219001610 | 10 VIAL in 1 CARTON (65219-016-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-016-01)Marketed from Aug 3, 2020 |
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 — 500 mg/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062719
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 65219-016_38c6c088-e4ab-4859-b4d9-89e846cf9d5fSPL ID 38c6c088-e4ab-4859-b4d9-89e846cf9d5fSPL set ID 8dbb4c71-8543-08f1-e053-2995a90af88dRxCUI 1721473, 1721474, 1721475, 1721476UNII JFN36L5S8K
- 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
N465219001610followed by a unit qualifier and the quantityPackage 65219-0016-10. 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 S. 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 organisms inclu…
Excerpt only. Read the full label for complete information.
About NDC 65219-016
- What is NDC 65219-016?
- 65219-016 is the product NDC for Ampicillin (ampicillin sodium), Ampicillin sodium 500 mg/1 injection, powder, 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?
- Ampicillin (Ampicillin sodium).
- What is the active ingredient?
- Ampicillin sodium.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ampicillin?
- 68 other product NDCs are listed under this name. See all Ampicillin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ampicillin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ampicillinampicillin sodium | Ampicillin sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9760 | 00404-9760-99 |
| Ampicillin | Ampicillin sodium 500 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-312 | 83270-0312-10 |
| Ampicillin | Ampicillin sodium 250 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-311 | 83270-0311-10 |
| Ampicillin | Ampicillin sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-313 | 83270-0313-10 |
| Ampicillin | Ampicillin sodium 2 g/1 | Injection, Powder, For solutionIntravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-314 | 83270-0314-10 |
| Ampicillin | Ampicillin sodium 10 g/1 | Injection, Powder, For solutionIntravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-315 | 83270-0315-01 |
| Ampicillin | Ampicillin sodium 10 g/1 | Injection, Powder, For solutionIntravenous | Armas Pharmaceuticals Inc. | 72485-423 | 72485-0423-10 |
| Ampicillinampicillin sodium | Ampicillin sodium 10 g/100mL | Injection, Powder, For solutionIntravenous | Avenacy Inc. | 83634-100 | 83634-0100-99 |
| Ampicillinampicillin injection | Ampicillin sodium 500 mg/500mg | Powder, For solutionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-915 | 23155-0915-41 |
| Ampicillinampicillin injection | Ampicillin sodium 250 mg/250mg | Powder, For solutionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-914 | 23155-0914-41 |
Other NDCs under ANDA 062719
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 250 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1595 |
| Ampicillinampicillin sodium | Ampicillin sodium 250 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 65219-014 |
| Ampicillinampicillin sodium | Ampicillin sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 65219-018 |
| Ampicillin | Ampicillin sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Civica, Inc. | 72572-016 |
| Ampicillinampicillin sodium | Ampicillin sodium 500 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | NorthStar Rx, LLC | 72603-221 |
| Ampicillinampicillin sodium | Ampicillin sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | NorthStar Rx, LLC | 72603-363 |