What is NDC 52427-285?

52427-285 is the product NDC for Macrobid, Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 capsule, listed with the FDA by Almatica Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Macrobid (Nitrofurantoin Monohydrate/Macrocrystalline).

What is the active ingredient?

Nitrofurantoin, Nitrofurantoin monohydrate.

Almatica Pharma LLC, NDC labeler code 52427. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Macrobid?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Macrobid NDC 52427-285 | National Drug Code

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	5242702850152427028501	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 LLCNDC labeler code 52427
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020064
Marketing start: May 31, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Nitrofurans (Chemical structure)Nitrofurans (Chemical structure)
Identifiers: Product ID 52427-285_a0e22b1a-3b68-4548-ab7e-58a3a068badcSPL ID a0e22b1a-3b68-4548-ab7e-58a3a068badc
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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 52427-285

What is NDC 52427-285?: 52427-285 is the product NDC for Macrobid, Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 capsule, listed with the FDA by Almatica Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Macrobid (Nitrofurantoin Monohydrate/Macrocrystalline).
What is the active ingredient?: Nitrofurantoin, Nitrofurantoin monohydrate.
Who is the labeler?: Almatica Pharma LLC, NDC labeler code 52427. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Macrobid?: 1 other product NDC are listed under this name. See all Macrobid NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Macrobid NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Macrobidnitrofurantoin monohydrate/macrocrystalline	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-2531	70518-2531-00

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
Macrobidnitrofurantoin monohydrate/macrocrystalline	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-2531
Nitrofurantoin Mononitrofurantoin monohydrate	Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1	CapsuleOral	PharmPak, Inc.	54348-849
Nitrofurantoin Monohydrate Macrocrystallinenitrofurantoin monohydrate	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Direct_Rx	61919-021
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/macrocrystalline	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-0265