Prescription drug · ANDA
NITROFURANTOIN (monohydrate/macrocrystals) NDC 67296-2180
Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 · Capsule · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2180-1 | 6729621800167296218001 | 10 CAPSULE in 1 BOTTLE (67296-2180-1)Marketed from Feb 22, 2022 | |
| 67296-2180-4 | 6729621800467296218004 | 14 CAPSULE in 1 BOTTLE (67296-2180-4)Marketed from Feb 22, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/macrocrystals)
- Generic name (nonproprietary)
- nitrofurantoin (monohydrate/macrocrystals)
- Active ingredients
- Nitrofurantoin monohydrate — 75 mg/1Nitrofurantoin — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Redpharm DrugNDC labeler code 67296
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211013
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)Nitrofurans (Chemical structure)
- Identifiers
- Product ID 67296-2180_44f6672a-3bb0-4beb-e063-6394a90aca9fSPL ID 44f6672a-3bb0-4beb-e063-6394a90aca9fSPL set ID 3dd034a6-8810-93f5-e063-6394a90a36c2RxCUI 1648755UNII E1QI2CQQ1I, 927AH8112LUPC 0359746762018, 0359746762360
- 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
N467296218001followed by a unit qualifier and the quantityPackage 67296-2180-01. 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 capsule (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsule (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. …
Excerpt only. Read the full label for complete information.
About NDC 67296-2180
- What is NDC 67296-2180?
- 67296-2180 is the product NDC for NITROFURANTOIN (monohydrate/macrocrystals), Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 capsule, listed with the FDA by Redpharm Drug. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- NITROFURANTOIN (monohydrate/macrocrystals).
- What is the active ingredient?
- Nitrofurantoin monohydrate, Nitrofurantoin.
- Who is the labeler?
- Redpharm Drug, NDC labeler code 67296. 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/macrocrystals)?
- 32 other product NDCs are listed under this name. See all NITROFURANTOIN (monohydrate/macrocrystals) 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/macrocrystals) 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/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1198 | 67046-1198-03 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1271 | 67046-1271-03 |
| Nitrofurantoin (Monohydrate/Macrocrystals) | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-147 | 82619-0147-0182619-0147-0282619-0147-03 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7571 | 00904-7571-61 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4358 | 70518-4358-00 |
| NITROFURANTOIN (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-065 | 82868-0065-1082868-0065-1482868-0065-20 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4026 | 70518-4026-0070518-4026-0170518-4026-02+1 more |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8571 | 68788-8571-0068788-8571-01 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-196 | 72603-0196-01 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-606 | 68001-0606-00 |
Other NDCs under ANDA 211013
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 |
|---|---|---|---|---|
| Nitrofurantoinnitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6664 |
| Nitrofurantoinnitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6750 |
| NITROFURANTOIN (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8531 |
| NITROFURANTOIN (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | QPharma, Inc. | 42708-184 |
| NITROFURANTOIN (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-762 |
| NITROFURANTOIN (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-884 |
| NITROFURANTOIN (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-065 |