Prescription drug · ANDA
Ampicillin NDC 59651-551
Ampicillin trihydrate 500 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-551-01 | 59651055101 | 100 CAPSULE in 1 BOTTLE (59651-551-01)Marketed from Oct 31, 2023 | |
| 59651-551-05 | 59651055105 | 500 CAPSULE in 1 BOTTLE (59651-551-05)Marketed from Oct 31, 2023 |
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
- Active ingredients
- Ampicillin trihydrate — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216554
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 59651-551_7aa396aa-691c-4b4d-9363-e977c1e0d44dSPL ID 7aa396aa-691c-4b4d-9363-e977c1e0d44dSPL set ID 7f8b1ab1-73c6-4cdf-a838-7a4554c62586RxCUI 308212, 313800UNII HXQ6A1N7R6UPC 0359651551011
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459651055101followed by a unit qualifier and the quantityPackage 59651-0551-01. 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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin capsules and other antibacterial drugs, ampicillin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting of modifying antimicrobial therapy, in the absence of such data, local epidemiology and susceptibility patterns contribute to the empiric selection of therapy. Ampicillin capsules are indicated in the treatment of infections caused by susceptible strains of the designated organisms listed below: Infections…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216554
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 trihydrate 250 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-550 |