Prescription drug · ANDA
Amoxicillin NDC 66267-994
Amoxicillin 250 mg/5mL · Powder, For suspension · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66267-994-00 | 66267099400 | 100 mL in 1 BOTTLE (66267-994-00)Marketed from Aug 24, 2017 |
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/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 061931
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 66267-994_1fa7e9c4-72e5-8c30-e063-6394a90a09cfSPL ID 1fa7e9c4-72e5-8c30-e063-6394a90a09cfSPL set ID 5780c9e4-5e22-270c-e053-2a91aa0a36baRxCUI 239191UNII 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
N466267099400followed by a unit qualifier and the quantityPackage 66267-0994-00. 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)
Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 to 1.4 ) In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) and other antibacterial drugs, amoxicillin capsules, amoxicillin for oral suspension, and amoxicillin tablets (chewable) should be used only to treat infections that are…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 061931
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 | Chartwell RX, LLC | 62135-089 |
| Amoxicillin | Amoxicillin 125 mg/5mL | Powder, For suspensionOral | Chartwell RX, LLC | 62135-109 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-2558 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Asclemed USA, Inc. | 76420-573 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 63187-186 |
| Amoxicillin | Amoxicillin 250 mg/5mL | Powder, For suspensionOral | Teva Pharmaceuticals USA, Inc. | 0093-4155 |