Prescription drug · ANDA
Amoxicillin NDC 68071-3517
Amoxicillin 500 mg/1 · Capsule · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3517-0 | 6807135170068071351700 | 15 CAPSULE in 1 BOTTLE (68071-3517-0)Marketed from Oct 6, 2023 | |
| 68071-3517-1 | 6807135170168071351701 | 21 CAPSULE in 1 BOTTLE (68071-3517-1)Marketed from Oct 6, 2023 | |
| 68071-3517-2 | 6807135170268071351702 | 20 CAPSULE in 1 BOTTLE (68071-3517-2)Marketed from Oct 6, 2023 | |
| 68071-3517-3 | 6807135170368071351703 | 30 CAPSULE in 1 BOTTLE (68071-3517-3)Marketed from Oct 6, 2023 | |
| 68071-3517-4 | 6807135170468071351704 | 40 CAPSULE in 1 BOTTLE (68071-3517-4)Marketed from Jun 6, 2024 | |
| 68071-3517-5 | 6807135170568071351705 | 56 CAPSULE in 1 BOTTLE (68071-3517-5)Marketed from Oct 6, 2023 | |
| 68071-3517-9 | 6807135170968071351709 | 10 CAPSULE in 1 BOTTLE (68071-3517-9)Marketed from Nov 13, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065271
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 68071-3517_437e7c62-fa62-3ec3-e063-6394a90a044dSPL ID 437e7c62-fa62-3ec3-e063-6394a90a044dSPL set ID 071086f5-e4ed-b1d9-e063-6294a90ad304RxCUI 308191UNII 804826J2HUUPC 0368071351736
- 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
N468071351700followed by a unit qualifier and the quantityPackage 68071-3517-00. 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.
About NDC 68071-3517
- What is NDC 68071-3517?
- 68071-3517 is the product NDC for Amoxicillin, Amoxicillin 500 mg/1 capsule, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 7 package NDCs, 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?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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?
- 277 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 065271
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 | NorthStar Rx LLC | 16714-298 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5019 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3574 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Redpharm Drug | 67296-1894 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Proficient Rx LP | 71205-507 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4455 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-574 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Proficient Rx LP | 71205-817 |
| Amoxicillin 500 mgamoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Health Department, Oklahoma State | 83112-500 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3119 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4548 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Sportpharm LLC | 85766-021 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Sportpharm LLC | 85766-267 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0895 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3235 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3832 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceutials,Inc. | 68071-3662 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0269 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | QPharma Inc | 42708-076 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Preferred Phamraceuticals Inc. | 68788-8209 |
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