Prescription drug · NDA
Nitrofurantoin Monohydrate/ Macrocrystalline NDC 47781-303
nitrofurantoin monohydrate/macrocrystalline · Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 · Capsule · Oral · Alvogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47781-303-01 | 47781030301 | 100 CAPSULE in 1 BOTTLE (47781-303-01)Marketed from May 25, 2011 |
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 Monohydrate/ Macrocrystalline
- Generic name (nonproprietary)
- nitrofurantoin monohydrate/macrocrystalline
- Active ingredients
- Nitrofurantoin — 25 mg/1Nitrofurantoin monohydrate — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Alvogen Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020064
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)Nitrofurans (Chemical structure)
- Identifiers
- Product ID 47781-303_c60467a9-d071-afab-5df9-a6642c176b09SPL ID c60467a9-d071-afab-5df9-a6642c176b09SPL set ID 1a86deef-0887-43b1-bb96-dbc222b15931RxCUI 1648755UNII 927AH8112L, E1QI2CQQ1IUPC 0347781303013
- 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
N447781030301followed by a unit qualifier and the quantityPackage 47781-0303-01. 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.
Other NDCs under NDA 020064
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 |
|---|---|---|---|---|
| Nitrofurantoin Monohydrate/ Macrocrystallinenitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Proficient Rx LP | 63187-263 |
| Nitrofurantoin Monohydrate Macrocrystallinenitrofurantoin monohydrate | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Direct_Rx | 61919-021 |
| Nitrofurantoin Mononitrofurantoin monohydrate | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | PharmPak, Inc. | 54348-849 |
| Macrobidnitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2531 |
| Macrobidnitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Almatica Pharma LLC | 52427-285 |
| Nitrofurantoin Monohydrate/ Macrocrystallinenitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0265 |