nitrofurantoin (macrocrystals) NDC 59651-753

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-753Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0753Add 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	Copy
59651-753-01	59651075301	100 CAPSULE in 1 BOTTLE (59651-753-01)Marketed from May 12, 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 — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074967
Marketing start: May 12, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Nitrofurans (Chemical structure)
Identifiers: Product ID 59651-753_bac7a3bd-df62-4b82-853c-f4d6ea650c62SPL ID bac7a3bd-df62-4b82-853c-f4d6ea650c62SPL set ID 158e08ff-9b6d-4d60-a218-74dc289cf023RxCUI 311995UNII 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

N459651075301 followed by a unit qualifier and the quantity

Package 59651-0753-01. 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 May 25, 2023.

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.

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