NDC codes

FDA NDC Directory
Product NDC (as listed)50268-623Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0623Add 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 NDC11-digit (billing)PackageCopy
50268-623-15502680623155026806231550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-623-15) / 1 CAPSULE in 1 BLISTER PACK (50268-623-11)Marketed from Dec 8, 2017

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
AvPAKNDC labeler code 50268
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 073671
Marketing start
Listing expires
Other FDA classes
Nitrofurans (Chemical structure)
Identifiers
Product ID 50268-623_4ba7ff07-0f36-ca5d-e063-6394a90a3357SPL ID 4ba7ff07-0f36-ca5d-e063-6394a90a3357SPL set ID 650f3c60-d45d-4358-a388-7efee4ad0497RxCUI 311995, 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

N450268062315 followed by a unit qualifier and the quantity

Package 50268-0623-15. 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 .

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 cau…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-623

What is NDC 50268-623?
50268-623 is the product NDC for Nitrofurantoin Macrocrystals, Nitrofurantoin 50 mg/1 capsule, listed with the FDA by AvPAK. 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?
AvPAK, NDC labeler code 50268. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
nitrofurantoin (macrocrystals)Nitrofurantoin 25 mg/1CapsuleOralAurobindo Pharma Limited59651-94259651-0942-01
Nitrofurantoin MacrocrystalsNitrofurantoin 50 mg/1CapsuleOralAmerican Health Packaging60687-83960687-0839-01
Nitrofurantoin MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralAmerican Health Packaging60687-85060687-0850-01
Nitrofurantoin MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralDirect_Rx61919-84261919-0842-1461919-0842-20
nitrofurantoin macrocrystalsNitrofurantoin 25 mg/1CapsuleOralNorthStar RxLLC72603-18272603-0182-01
nitrofurantoin macrocrystalsNitrofurantoin 50 mg/1CapsuleOralNorthStar RxLLC72603-18372603-0183-01
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralNorthStar RxLLC72603-18472603-0184-01
nitrofurantoin macrocrystalsNitrofurantoin 25 mg/1CapsuleOralBluePoint Laboratories68001-60368001-0603-00
nitrofurantoin macrocrystalsNitrofurantoin 50 mg/1CapsuleOralBluePoint Laboratories68001-60468001-0604-00
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralBluePoint Laboratories68001-60568001-0605-00

All 39 Nitrofurantoin Macrocrystals NDCs

Other NDCs under ANDA 073671

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

FDA NDC Directory listings under ANDA 073671
ProductStrengthForm · routeLabelerProduct NDC
Nitrofurantoin MacrocrystalsNitrofurantoin 50 mg/1CapsuleOralAmneal Pharmaceuticals of New York LLC0115-1643

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