Prescription drug · ANDA
nitrofurantoin (macrocrystals) NDC 50090-7308
Nitrofurantoin 100 mg/1 · Capsule · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7308-0 | 5009073080050090730800 | 28 CAPSULE in 1 BOTTLE (50090-7308-0)Marketed from Oct 14, 2024 | |
| 50090-7308-2 | 5009073080250090730802 | 20 CAPSULE in 1 BOTTLE (50090-7308-2)Marketed from Oct 14, 2024 | |
| 50090-7308-3 | 5009073080350090730803 | 14 CAPSULE in 1 BOTTLE (50090-7308-3)Marketed from Oct 14, 2024 |
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 (macrocrystals)
- Generic name (nonproprietary)
- nitrofurantoin (macrocrystals)
- Active ingredients
- Nitrofurantoin — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077025
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 50090-7308_b0e07675-526a-4083-a35e-2a93ad10888bSPL ID b0e07675-526a-4083-a35e-2a93ad10888bSPL set ID bc90b22e-e48a-4a22-b328-ca5bb2561864RxCUI 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
N450090730800followed by a unit qualifier and the quantityPackage 50090-7308-00. 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, nitrofurantoin 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 50090-7308
- What is NDC 50090-7308?
- 50090-7308 is the product NDC for nitrofurantoin (macrocrystals), Nitrofurantoin 100 mg/1 capsule, listed with the FDA by A-S Medication Solutions. It has 3 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 ANDA 077025
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 |
|---|---|---|---|---|
| nitrofurantoin (macrocrystals) | Nitrofurantoin 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-795 |
| nitrofurantoin (macrocrystals) | Nitrofurantoin 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-942 |