Prescription drug · ANDA
Amoxicillin NDC 68999-825
Amoxicillin 500 mg/1 · Capsule · Oral · Chartwell Governmental & Specialty RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68999-825-01 | 68999082501 | 100 CAPSULE in 1 BOTTLE (68999-825-01)Marketed from Jun 24, 2022 | |
| 68999-825-60 | 68999082560 | 60 CAPSULE in 1 BOTTLE (68999-825-60)Marketed from Jun 24, 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 — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062058
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 68999-825_46911108-ba5e-8cba-e063-6294a90adcccSPL ID 46911108-ba5e-8cba-e063-6294a90adcccSPL set ID f9062321-ffb3-42e8-8f98-453cd30f5282RxCUI 308182, 308191UNII 804826J2HUUPC 0368999824015, 0368999825609, 0368999825012
- 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
N468999082501followed by a unit qualifier and the quantityPackage 68999-0825-01. 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 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 capsules 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 capsules are indicated in the treatment of infections due to…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062058
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 | CapsuleOral | Chartwell Governmental & Specialty RX, LLC | 68999-824 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-825 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-824 |