Prescription drug · NDA
Nitrofurantoin Monohydrate Macrocrystalline (Nitrofurantoin monohydrate) NDC 61919-021
Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 · Capsule · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-021-02 | 6191900210261919002102 | 2 CAPSULE in 1 BOTTLE (61919-021-02)Marketed from Jul 8, 2019 | |
| 61919-021-10 | 6191900211061919002110 | 10 CAPSULE in 1 BOTTLE (61919-021-10)Marketed from Jul 8, 2019 | |
| 61919-021-14 | 6191900211461919002114 | 14 CAPSULE in 1 BOTTLE (61919-021-14)Marketed from Jul 8, 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 Monohydrate Macrocrystalline
- Generic name (nonproprietary)
- nitrofurantoin monohydrate
- Active ingredients
- Nitrofurantoin — 25 mg/1Nitrofurantoin monohydrate — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 61919
- 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 61919-021_397f7645-278c-731e-e063-6294a90a2d3fSPL ID 397f7645-278c-731e-e063-6294a90a2d3fSPL set ID 8d2e456a-ffb2-3f1e-e053-2995a90a22dfRxCUI 1648755UNII 927AH8112L, E1QI2CQQ1I
- 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
N461919002102followed by a unit qualifier and the quantityPackage 61919-0021-02. 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)
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. When culture and susceptib…
Excerpt only. Read the full label for complete information.
About NDC 61919-021
- What is NDC 61919-021?
- 61919-021 is the product NDC for Nitrofurantoin Monohydrate Macrocrystalline, Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 capsule, listed with the FDA by Direct_Rx. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrofurantoin Monohydrate Macrocrystalline (Nitrofurantoin monohydrate).
- What is the active ingredient?
- Nitrofurantoin, Nitrofurantoin monohydrate.
- Who is the labeler?
- Direct_Rx, NDC labeler code 61919. 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/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 |
| Nitrofurantoin Monohydrate/ Macrocrystallinenitrofurantoin monohydrate/macrocrystalline | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Proficient Rx LP | 63187-263 | 63187-0263-1063187-0263-1463187-0263-28+2 more |
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/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 |