Prescription drug · ANDA
Amoxicillin NDC 82868-063
Amoxicillin 250 mg/1 · Tablet, Chewable · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82868-063-30 | 8286800633082868006330 | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82868-063-30)Marketed from Jul 18, 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 — 250 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Northwind Health Company, LLCNDC labeler code 82868
- 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 82868-063_5632652e-d892-d926-e063-6394a90ac023SPL ID 5632652e-d892-d926-e063-6394a90ac023SPL set ID 26e257d5-5b98-3795-e063-6394a90a05bcRxCUI 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
N482868006330followed by a unit qualifier and the quantityPackage 82868-0063-30. 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.
About NDC 82868-063
- What is NDC 82868-063?
- 82868-063 is the product NDC for Amoxicillin, Amoxicillin 250 mg/1 tablet, chewable, listed with the FDA by Northwind Health Company, 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?
- Northwind Health Company, LLC, NDC labeler code 82868. 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?
- 274 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 250 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-088 | 82868-0088-30 |
| 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 |
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 | PD-Rx Pharmaceuticals, Inc. | 55289-182 |
| 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 |
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | NuCare Pharmaceuticals, Inc. | 66267-022 |
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | PD-Rx Pharmaceuticals, Inc. | 43063-341 |
| Amoxicillin | Amoxicillin 250 mg/1 | Tablet, ChewableOral | NuCare Pharmaceuticals,Inc. | 66267-871 |
| 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 | 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 |