Prescription drug · ANDA
Amoxicillin NDC 72789-224
Amoxicillin 875 mg/1 · Tablet, Coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-224-01 | 72789022401 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-224-01)Marketed from Feb 10, 2022 |
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 — 875 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065255
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 72789-224_40ad11b9-8246-8d3f-e063-6294a90a26ebSPL ID 40ad11b9-8246-8d3f-e063-6294a90a26ebSPL set ID b397d4be-d2ef-419a-98ac-844069c99d56RxCUI 308194UNII 804826J2HUUPC 0372789224015
- 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
N472789022401followed by a unit qualifier and the quantityPackage 72789-0224-01. 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)
Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets 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 are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli , Proteus mirabilis , or Enterococcus faecalis . Infections of the Skin and Skin Structure: Amoxicillin tablets are indicated in the treatment of infections due to sus…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065255
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 875 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-5863 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-5880 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, CoatedOral | Hikma Pharmaceuticals USA Inc. | 0143-9285 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 82804-200 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals, Inc. | 68071-3716 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-4062 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, CoatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-885 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, CoatedOral | Redpharm Drug | 67296-2328 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, CoatedOral | Asclemed USA, Inc. | 76420-138 |