Prescription drug · NDA
Nitrofurantoin Monohydrate/ Macrocrystalline NDC 63187-263
nitrofurantoin monohydrate/macrocrystalline · Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-263-10 | 6318702631063187026310 | 10 CAPSULE in 1 BOTTLE (63187-263-10)Marketed from Nov 1, 2018 | |
| 63187-263-14 | 6318702631463187026314 | 14 CAPSULE in 1 BOTTLE (63187-263-14)Marketed from Nov 1, 2018 | |
| 63187-263-28 | 6318702632863187026328 | 28 CAPSULE in 1 BOTTLE (63187-263-28)Marketed from Nov 1, 2018 | |
| 63187-263-30 | 6318702633063187026330 | 30 CAPSULE in 1 BOTTLE (63187-263-30)Marketed from Nov 1, 2018 | |
| 63187-263-60 | 6318702636063187026360 | 60 CAPSULE in 1 BOTTLE (63187-263-60)Marketed from Nov 1, 2018 |
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
- Proficient Rx LPNDC labeler code 63187
- 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 63187-263_46ff38b8-3cbb-4e18-b66f-703b572a37f6SPL ID 46ff38b8-3cbb-4e18-b66f-703b572a37f6SPL set ID 22061f76-2c05-4501-b8dd-a5c372abe7c2RxCUI 1648755UNII 927AH8112L, E1QI2CQQ1IUPC 0363187263102
- 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
N463187026310followed by a unit qualifier and the quantityPackage 63187-0263-10. 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 monohydrate/macrocrystals capsules 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 monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Whe…
Excerpt only. Read the full label for complete information.
About NDC 63187-263
- What is NDC 63187-263?
- 63187-263 is the product NDC for Nitrofurantoin Monohydrate/ Macrocrystalline, Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrofurantoin Monohydrate/ Macrocrystalline (Nitrofurantoin Monohydrate/Macrocrystalline).
- What is the active ingredient?
- Nitrofurantoin, Nitrofurantoin monohydrate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nitrofurantoin Monohydrate/ Macrocrystalline?
- 3 other product NDCs are listed under this name. See all Nitrofurantoin Monohydrate/ Macrocrystalline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nitrofurantoin Monohydrate/ Macrocrystalline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nitrofurantoin Monohydrate Macrocrystallinenitrofurantoin monohydrate | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Direct_Rx | 61919-021 | 61919-0021-0261919-0021-1061919-0021-14 |
| Nitrofurantoin Monohydrate/ Macrocrystallinenitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0265 | 70518-0265-03 |
| Nitrofurantoin Monohydrate/ Macrocrystallinenitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Alvogen Inc. | 47781-303 | 47781-0303-01 |
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 |
|---|---|---|---|---|
| Macrobidnitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Almatica Pharma LLC | 52427-285 |
| Macrobidnitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2531 |
| Nitrofurantoin Mononitrofurantoin monohydrate | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | PharmPak, Inc. | 54348-849 |
| Nitrofurantoin Monohydrate Macrocrystallinenitrofurantoin monohydrate | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Direct_Rx | 61919-021 |
| Nitrofurantoin Monohydrate/ Macrocrystallinenitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Alvogen Inc. | 47781-303 |
| Nitrofurantoin Monohydrate/ Macrocrystallinenitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0265 |