Prescription drug · ANDA
Nitrofurantoin (monohydrate/macrocrystals) NDC 82804-115
Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-115-10 | 8280401151082804011510 | 10 CAPSULE in 1 BOTTLE (82804-115-10)Marketed from Jul 8, 2024 | |
| 82804-115-14 | 8280401151482804011514 | 14 CAPSULE in 1 BOTTLE (82804-115-14)Marketed from Jul 16, 2024 | |
| 82804-115-20 | 8280401152082804011520 | 20 CAPSULE in 1 BOTTLE (82804-115-20)Marketed from Jul 24, 2024 |
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/macrocrystals)
- Generic name (nonproprietary)
- nitrofurantoin (monohydrate/macrocrystals)
- Active ingredients
- Nitrofurantoin monohydrate — 75 mg/1Nitrofurantoin — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217357
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)Nitrofurans (Chemical structure)
- Identifiers
- Product ID 82804-115_ad3c1b1b-ca8b-4976-aba5-aed2f338dd92SPL ID ad3c1b1b-ca8b-4976-aba5-aed2f338dd92SPL set ID f49f586a-79f0-4731-97f9-9aeb0839ece5RxCUI 1648755UNII E1QI2CQQ1I, 927AH8112LUPC 0382804115143
- 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
N482804011510followed by a unit qualifier and the quantityPackage 82804-0115-10. 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 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.
About NDC 82804-115
- What is NDC 82804-115?
- 82804-115 is the product NDC for Nitrofurantoin (monohydrate/macrocrystals), Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 3 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?
- Proficient Rx LP, NDC labeler code 82804. 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 217357
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 | NuCare Pharmaceuticals,Inc. | 68071-3569 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7571 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1198 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1271 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Redpharm Drug | 67296-2105 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-606 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3593 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8571 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4026 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4358 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Lifestar Pharma LLC | 70756-404 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2377 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-196 |