Prescription drug · ANDA
Amoxicillin NDC 85534-0070
Amoxicillin 125 mg/5mL · Powder, For suspension · Oral · HAWAII REPACK, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85534-0070-0 | 85534007000 | 80 mL in 1 BOTTLE (85534-0070-0)Marketed from Jul 3, 2026 | |
| 85534-0070-1 | 85534007001 | 100 mL in 1 BOTTLE (85534-0070-1)Marketed from Jul 3, 2026 | |
| 85534-0070-2 | 85534007002 | 150 mL in 1 BOTTLE (85534-0070-2)Marketed from Jul 3, 2026 |
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 — 125 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- HAWAII REPACK, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065387
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 85534-0070_55af4d00-f2af-456b-e063-6394a90a75e5SPL ID 55af4d00-f2af-456b-e063-6394a90a75e5SPL set ID 669a243e-249d-4ccb-9693-66de073e53bbRxCUI 239191, 308189, 313797, 313850UNII 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
N485534007000followed by a unit qualifier and the quantityPackage 85534-0070-00. 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 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 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 is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065387
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/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4581 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Sandoz Inc | 0781-6039 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Sandoz Inc | 0781-6041 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6056 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 63187-880 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals, Inc. | 68788-9949 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals, Inc. | 68788-9948 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4969 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-266 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | HAWAII REPACK, INC. | 85534-0072 |