Prescription drug · ANDA
Nitrofurantoin NDC 42571-393
Nitrofurantoin 100 mg/1 · Capsule · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-393-01 | 42571039301 | 100 CAPSULE in 1 BOTTLE (42571-393-01)Marketed from Apr 1, 2024 | |
| 42571-393-05 | 42571039305 | 500 CAPSULE in 1 BOTTLE (42571-393-05)Marketed from Apr 1, 2024 | |
| 42571-393-90 | 42571039390 | 90 CAPSULE in 1 BOTTLE (42571-393-90)Marketed from Apr 1, 2024 |
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)
- Nitrofurantoin
- Generic name (nonproprietary)
- nitrofurantoin
- Active ingredients
- Nitrofurantoin — 100 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 217073
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 42571-393_35155f61-5d28-d364-e063-6294a90aa4c6SPL ID 35155f61-5d28-d364-e063-6294a90aa4c6SPL set ID d96098d0-3c2b-4e53-a3f0-3ebba81c4133RxCUI 1648755UNII 927AH8112LUPC 0342571393908
- Pharmacologic class
- Nitrofuran 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
N442571039301followed by a unit qualifier and the quantityPackage 42571-0393-01. 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)
INDICATIONS AND USAGE Nitrofurantoin capsules (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus . Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteri…
Excerpt only. Read the full label for complete information.