What is NDC 43386-642?

43386-642 is the product NDC for Nitrofurantoin macrocrystals, Nitrofurantoin 100 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nitrofurantoin macrocrystals NDC 43386-642

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-642Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0642Add 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
43386-642-01	4338606420143386064201	100 CAPSULE in 1 BOTTLE (43386-642-01)Marketed from Jul 9, 2018

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 — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203233
Marketing start: Jul 9, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Nitrofurans (Chemical structure)
Identifiers: Product ID 43386-642_2e7ec48f-d605-4e97-8620-299e5f143026SPL ID 2e7ec48f-d605-4e97-8620-299e5f143026SPL set ID 52168b36-4e95-4d5b-82be-bbb91c7dcb90RxCUI 311995, 1648759UNII 927AH8112LUPC 0343386642106, 0343386642014, 0343386641109, 0343386641017
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

N443386064201 followed by a unit qualifier and the quantity

Package 43386-0642-01. 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 Jan 30, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nitrofurantoin capsules USP, (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 USP, (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules USP, (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43386-642

What is NDC 43386-642?: 43386-642 is the product NDC for Nitrofurantoin macrocrystals, Nitrofurantoin 100 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, 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?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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.

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

Other Nitrofurantoin macrocrystals NDCs
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

All 39 Nitrofurantoin macrocrystals NDCs

Other NDCs under ANDA 203233

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

FDA NDC Directory listings under ANDA 203233
Product	Strength	Form · route	Labeler	Product NDC
Nitrofurantoin macrocrystals	Nitrofurantoin 50 mg/1	CapsuleOral	Lupin Pharmaceuticals,Inc.	43386-641