Prescription drug · ANDA
Amoxicillin NDC 42708-078
Amoxicillin 875 mg/1 · Tablet, Film coated · Oral · QPharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42708-078-20 | 42708007820 | 20 TABLET, FILM COATED in 1 BOTTLE (42708-078-20)Marketed from Jan 14, 2019 · Sample package |
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, Film coated
- Route
- Oral
- Labeler
- QPharma, Inc.NDC labeler code 42708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065256
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 42708-078_45867f6f-f9ed-c4aa-e063-6394a90a0cc3SPL ID 45867f6f-f9ed-c4aa-e063-6394a90a0cc3SPL set ID 2700df91-c5ef-4931-9ad7-a3c1c146ccacRxCUI 308194UNII 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
N442708007820followed by a unit qualifier and the quantityPackage 42708-0078-20. 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.
About NDC 42708-078
- What is NDC 42708-078?
- 42708-078 is the product NDC for Amoxicillin, Amoxicillin 875 mg/1 tablet, film coated, listed with the FDA by QPharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amoxicillin.
- What is the active ingredient?
- Amoxicillin.
- Who is the labeler?
- QPharma, Inc., NDC labeler code 42708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amoxicillin?
- 268 other product NDCs are listed under this name. See all Amoxicillin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amoxicillin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0734 | 67046-0734-03 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4152 | 68788-4152-02 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Coupler LLC | 67046-0316 | 67046-0316-03 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Coupler LLC | 67046-0127 | 67046-0127-03 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0015 | 67046-0015-03 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Coupler LLC | 67046-1175 | 67046-1175-03 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-4062 | 68788-4062-02 |
| Amoxicillin | Amoxicillin 400 mg/5mL | For suspensionOral | REMEDYREPACK INC. | 70518-4529 | 70518-4529-00 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | REMEDYREPACK INC. | 70518-4522 | 70518-4522-00 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | REMEDYREPACK INC. | 70518-4521 | 70518-4521-00 |
Other NDCs under ANDA 065256
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 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0709 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0713 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0714 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1595 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1596 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1825 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-028 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-029 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-798 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-809 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-325 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-729 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4777 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-015 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0015 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0734 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2911 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3675 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3872 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3890 |
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