Prescription drug · ANDA
Amoxicillin NDC 68788-8731
Amoxicillin 400 mg/5mL · Powder, For suspension · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8731-1 | 68788873101 | 100 mL in 1 BOTTLE (68788-8731-1)Marketed from Sep 16, 2024 |
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 — 400 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065119
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 68788-8731_f1194a1f-53b3-46d4-9dc5-112f9e0eb773SPL ID f1194a1f-53b3-46d4-9dc5-112f9e0eb773SPL set ID 8dfbaa75-87ba-4a6b-a2db-176441a842afRxCUI 308189UNII 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
N468788873101followed by a unit qualifier and the quantityPackage 68788-8731-01. 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065119
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 200 mg/5mL | Powder, For suspensionOral | Teva Pharmaceuticals USA, Inc. | 0093-4160 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Teva Pharmaceuticals USA, Inc. | 0093-4161 |
| Amoxicillin | Amoxicillin 200 mg/5mL | Powder, For suspensionOral | Chartwell RX, LLC | 62135-088 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Chartwell RX, LLC | 62135-090 |
| Amoxicillin | Amoxicillin 200 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8611 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-177 |