Prescription drug · NDA
Nitrofurantoin Mono (Nitrofurantoin monohydrate) NDC 54348-849
Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 · Capsule · Oral · PharmPak, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54348-849-06 | 5434808490654348084906 | 1 BOTTLE in 1 BOX (54348-849-06) / 6 CAPSULE in 1 BOTTLEMarketed from Jul 10, 2019 | |
| 54348-849-10 | 5434808491054348084910 | 1 BOTTLE in 1 BOX (54348-849-10) / 10 CAPSULE in 1 BOTTLEMarketed from Jul 10, 2019 | |
| 54348-849-14 | 5434808491454348084914 | 1 BOTTLE in 1 BOX (54348-849-14) / 14 CAPSULE in 1 BOTTLEMarketed from Jul 10, 2019 |
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 Mono
- Generic name (nonproprietary)
- nitrofurantoin monohydrate
- Active ingredients
- Nitrofurantoin monohydrate — 75 mg/1Nitrofurantoin — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- PharmPak, Inc.NDC labeler code 54348
- 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 54348-849_eaa5e1eb-d68d-a3f7-e053-2995a90aa735SPL ID eaa5e1eb-d68d-a3f7-e053-2995a90aa735SPL set ID d9840719-271f-42a9-a5c9-3e039ec8fbacRxCUI 1648755UNII E1QI2CQQ1I, 927AH8112L
- 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
N454348084906followed by a unit qualifier and the quantityPackage 54348-0849-06. 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 54348-849
- What is NDC 54348-849?
- 54348-849 is the product NDC for Nitrofurantoin Mono (nitrofurantoin monohydrate), Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 capsule, listed with the FDA by PharmPak, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrofurantoin Mono (Nitrofurantoin monohydrate).
- What is the active ingredient?
- Nitrofurantoin monohydrate, Nitrofurantoin.
- Who is the labeler?
- PharmPak, Inc., NDC labeler code 54348. 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 Mono?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 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 | Proficient Rx LP | 63187-263 |
| Nitrofurantoin Monohydrate/ Macrocrystallinenitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0265 |