Prescription drug · ANDA
Amoxicillin NDC 42571-233
Amoxicillin 250 mg/1 · Capsule · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-233-01 | 42571023301 | 100 CAPSULE in 1 BOTTLE (42571-233-01)Marketed from Nov 1, 2022 | |
| 42571-233-05 | 42571023305 | 500 CAPSULE in 1 BOTTLE (42571-233-05)Marketed from Nov 1, 2022 | |
| 42571-233-10 | 42571023310 | 1000 CAPSULE in 1 BOTTLE (42571-233-10)Marketed from Nov 1, 2022 | |
| 42571-233-30 | 42571023330 | 30 CAPSULE in 1 BOTTLE (42571-233-30)Marketed from Nov 1, 2022 |
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/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Micro Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207471
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 42571-233_238f9a44-0678-eb7c-e063-6394a90a4c73SPL ID 238f9a44-0678-eb7c-e063-6394a90a4c73SPL set ID 42f935ca-45ba-4b3e-8b40-9b2d4eb56281RxCUI 308182, 308191UNII 804826J2HUUPC 0342571234300, 0342571233303
- 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
N442571023301followed by a unit qualifier and the quantityPackage 42571-0233-01. 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)
Amoxicillin capsules are 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 and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Infections of the Ear, Nose, and Throat Amoxicillin caps…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207471
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 500 mg/1 | CapsuleOral | Micro Labs Limited | 42571-234 |