nitrofurantoin (macrocrystals) NDC 50090-7308

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-7308Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-7308Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
50090-7308-0	50090730800	28 CAPSULE in 1 BOTTLE (50090-7308-0)Marketed from Oct 14, 2024
50090-7308-2	50090730802	20 CAPSULE in 1 BOTTLE (50090-7308-2)Marketed from Oct 14, 2024
50090-7308-3	50090730803	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 Solutions
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077025
Marketing start: May 17, 2023
Listing expires: Dec 31, 2026
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

N450090730800 followed by a unit qualifier and the quantity

Package 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 Oct 15, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077025

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077025
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