Macrobid NDC 52427-285

NDC codes

FDA NDC Directory

Product NDC (as listed)52427-285Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52427-0285Add 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
52427-285-01	52427028501	100 CAPSULE in 1 BOTTLE (52427-285-01)Marketed from May 31, 2011

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): Macrobid
Generic name (nonproprietary): nitrofurantoin monohydrate/macrocrystalline
Active ingredients: Nitrofurantoin — 25 mg/1Nitrofurantoin monohydrate — 75 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Almatica Pharma LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020064
Marketing start: May 31, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Nitrofurans (Chemical structure)Nitrofurans (Chemical structure)
Identifiers: Product ID 52427-285_83236f78-20ec-6005-4b09-cc2470a1b36aSPL ID 83236f78-20ec-6005-4b09-cc2470a1b36aSPL set ID 8f270a9f-12a1-44d4-bc7e-873613555801RxCUI 539712, 1648755UNII 927AH8112L, E1QI2CQQ1IUPC 0352427285011
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

N452427028501 followed by a unit qualifier and the quantity

Package 52427-0285-01. 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 Oct 14, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Macrobid is 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 Macrobid and other antibacterial drugs, Macrobid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020064

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

FDA NDC Directory listings under NDA 020064
Product	Strength	Form · route	Labeler	Product NDC
Nitrofurantoin Monohydrate/ Macrocrystallinenitrofurantoin monohydrate/macrocrystalline	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Alvogen Inc.	47781-303
Nitrofurantoin Monohydrate/ Macrocrystallinenitrofurantoin monohydrate/macrocrystalline	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Proficient Rx LP	63187-263
Nitrofurantoin Monohydrate Macrocrystallinenitrofurantoin monohydrate	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Direct_Rx	61919-021
Nitrofurantoin Mononitrofurantoin monohydrate	Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1	CapsuleOral	PharmPak, Inc.	54348-849
Macrobidnitrofurantoin monohydrate/macrocrystalline	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-2531
Nitrofurantoin Monohydrate/ Macrocrystallinenitrofurantoin monohydrate/macrocrystalline	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-0265