Prescription drug · ANDA
Amoxicillin NDC 62135-815
Amoxicillin 400 mg/5mL · Powder, For suspension · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-815-42 | 62135081542 | 100 mL in 1 BOTTLE (62135-815-42)Marketed from Jun 25, 2024 |
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 — 400 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065319
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 62135-815_4690e611-3a29-35ce-e063-6294a90a5e9eSPL ID 4690e611-3a29-35ce-e063-6294a90a5e9eSPL set ID 1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92fRxCUI 308189UNII 804826J2HUUPC 0362135815424
- 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
N462135081542followed by a unit qualifier and the quantityPackage 62135-0815-42. 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 for oral suspension is 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 for oral suspension is 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 for oral suspension is indicated in the t…
Excerpt only. Read the full label for complete information.
About NDC 62135-815
- What is NDC 62135-815?
- 62135-815 is the product NDC for Amoxicillin, Amoxicillin 400 mg/5mL powder, for suspension, listed with the FDA by Chartwell RX, LLC. 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?
- Chartwell RX, LLC, NDC labeler code 62135. 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 |