Prescription drug · NDA
nitrofurantoin macrocrystals NDC 51655-948
Nitrofurantoin 100 mg/1 · Capsule · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-948-20 | 5165509482051655094820 | 20 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-20)Marketed from Feb 20, 2023 | |
| 51655-948-29 | 5165509482951655094829 | 28 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-29)Marketed from Feb 20, 2023 | |
| 51655-948-53 | 5165509485351655094853 | 10 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-53)Marketed from Aug 31, 2023 | |
| 51655-948-84 | 5165509488451655094884 | 14 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-84)Marketed from May 9, 2023 |
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 macrocrystals
- Generic name (nonproprietary)
- nitrofurantoin macrocrystals
- Active ingredients
- Nitrofurantoin — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Northwind Health Company, LLCNDC labeler code 51655
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016620
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 51655-948_49748854-b59f-adc7-e063-6394a90afab7SPL ID 49748854-b59f-adc7-e063-6394a90afab7SPL set ID f78102eb-cbed-801a-e053-6294a90ab880RxCUI 1648759UNII 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
N451655094820followed by a unit qualifier and the quantityPackage 51655-0948-20. 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 (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. 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 (macrocrystals) and other antibacterial drugs, nnitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susce…
Excerpt only. Read the full label for complete information.
About NDC 51655-948
- What is NDC 51655-948?
- 51655-948 is the product NDC for nitrofurantoin macrocrystals, Nitrofurantoin 100 mg/1 capsule, listed with the FDA by Northwind Health Company, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- nitrofurantoin macrocrystals.
- What is the active ingredient?
- Nitrofurantoin.
- Who is the labeler?
- Northwind Health Company, LLC, NDC labeler code 51655. 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 macrocrystals?
- 38 other product NDCs are listed under this name. See all nitrofurantoin 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 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 (macrocrystals) | Nitrofurantoin 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-942 | 59651-0942-01 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | American Health Packaging | 60687-839 | 60687-0839-01 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | American Health Packaging | 60687-850 | 60687-0850-01 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Direct_Rx | 61919-842 | 61919-0842-1461919-0842-20 |
| nitrofurantoin macrocrystals | Nitrofurantoin 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-182 | 72603-0182-01 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-183 | 72603-0183-01 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-184 | 72603-0184-01 |
| nitrofurantoin macrocrystals | Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-603 | 68001-0603-00 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-604 | 68001-0604-00 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-605 | 68001-0605-00 |
Other NDCs under NDA 016620
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 |
|---|---|---|---|---|
| Nitrofurantion Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-245 |
| Nitrofurantion Macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | Proficient Rx LP | 71205-023 |