Prescription drug · ANDA
Amoxicillin NDC 0093-4160
Amoxicillin 200 mg/5mL · Powder, For suspension · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-4160-73 | 00093416073 | 100 mL in 1 BOTTLE (0093-4160-73)Marketed from Apr 2, 2003 | |
| 0093-4160-76 | 00093416076 | 50 mL in 1 BOTTLE (0093-4160-76)Marketed from Jul 1, 2003 | |
| 0093-4160-78 | 00093416078 | 75 mL in 1 BOTTLE (0093-4160-78)Marketed from Jul 1, 2003 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 200 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 0093-4160_31223839-1653-4906-826a-f9d6af179334SPL ID 31223839-1653-4906-826a-f9d6af179334SPL set ID 4c0f348a-a65d-409c-8668-207c82a5e3cbRxCUI 239191, 308177, 308182, 308189, 308191, 308192, 308194, 313850, 598025UNII 804826J2HUUPC 0300933107051, 0300932264014, 0300934161731, 0300933109055, 0300932267015, 0300932268012, 0300932263017, 0300934160734, 0300934155730
- 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
N400093416073followed by a unit qualifier and the quantityPackage 00093-4160-73. 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.
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 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 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8731 |