Prescription drug · ANDA
Amoxicillin NDC 43063-341
Amoxicillin 250 mg/1 · Tablet, Chewable · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-341-04 | 43063034104 | 4 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-341-04)Marketed from Nov 26, 2011 |
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)
- Amoxicillin
- Generic name (nonproprietary)
- amoxicillin
- Active ingredients
- Amoxicillin — 250 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064013
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 43063-341_3a24c129-074d-c363-e063-6394a90a3a3aSPL ID 3a24c129-074d-c363-e063-6394a90a3a3aSPL set ID 09660a95-a7b3-4d1f-832c-a4fa7a5b7dddRxCUI 598025UNII 804826J2HU
- 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
N443063034104followed by a unit qualifier and the quantityPackage 43063-0341-04. 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)
Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of E…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 064013
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 |
|---|---|---|---|---|
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | NuCare Pharmaceuticals,Inc. | 66267-871 |
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 63187-343 |
| Amoxicillin | Amoxicillin 125 mg/1 | Tablet, ChewableOral | Chartwell RX, LLC | 62135-086 |
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | Chartwell RX, LLC | 62135-087 |
| Amoxicillin | Amoxicillin 125 mg/1 | Tablet, ChewableOral | Teva Pharmaceuticals USA, Inc. | 0093-2267 |
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | Teva Pharmaceuticals USA, Inc. | 0093-2268 |
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | Northwind Health Company, LLC | 82868-063 |
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | PD-Rx Pharmaceuticals, Inc. | 55289-182 |
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | NuCare Pharmaceuticals, Inc. | 66267-022 |
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-0454 |
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | A-S Medication Solutions | 50090-0455 |