NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2363Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2363Add 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
68071-2363-7680712363076807123630714 CAPSULE in 1 BOTTLE (68071-2363-7)Marketed from Mar 11, 2021
68071-2363-8680712363086807123630828 CAPSULE in 1 BOTTLE (68071-2363-8)Marketed from Mar 11, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Nitrofurantion
Generic name (nonproprietary)
nitrofurantion
Active ingredients
Nitrofurantoin — 100 mg/1
Dosage form
Capsule
Route
Oral
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201722
Marketing start
Listing expires
Other FDA classes
Nitrofurans (Chemical structure)
Identifiers
Product ID 68071-2363_4b353a66-abe4-a233-e063-6294a90a685dSPL ID 4b353a66-abe4-a233-e063-6294a90a685dSPL set ID bd46cc46-0efa-d5d9-e053-2995a90a18f1RxCUI 1648759UNII 927AH8112LUPC 0368071236378
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

N468071236307 followed by a unit qualifier and the quantity

Package 68071-2363-07. 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) is 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 ca…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-2363

What is NDC 68071-2363?
68071-2363 is the product NDC for Nitrofurantion, Nitrofurantoin 100 mg/1 capsule, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nitrofurantion.
What is the active ingredient?
Nitrofurantoin.
Who is the labeler?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nitrofurantion?
9 other product NDCs are listed under this name. See all Nitrofurantion 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 Nitrofurantion NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NitrofurantionNitrofurantoin 25 mg/1CapsuleOralBluePoint Labortories68001-38468001-0384-00
NitrofurantionNitrofurantoin 50 mg/1CapsuleOralBluePoint Labortories68001-38568001-0385-00
NitrofurantionNitrofurantoin 100 mg/1CapsuleOralBluePoint Labortories68001-38668001-0386-00
NitrofurantionNitrofurantoin 100 mg/1CapsuleOralA-S Medication Solutions50090-569350090-5693-0050090-5693-0250090-5693-03
NitrofurantionNitrofurantoin 25 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-23157664-0231-1857664-0231-88
NitrofurantionNitrofurantoin 50 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-23257664-0232-1857664-0232-88
NitrofurantionNitrofurantoin 100 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-23357664-0233-1857664-0233-88
NitrofurantionNitrofurantoin 100 mg/1CapsuleOralProficient Rx LP71205-17171205-0171-1071205-0171-1471205-0171-20+1 more
NitrofurantionNitrofurantoin 100 mg/1CapsuleOralBryant Ranch Prepack71335-002471335-0024-0171335-0024-0271335-0024-03+6 more

Other NDCs under ANDA 201722

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

FDA NDC Directory listings under ANDA 201722
ProductStrengthForm · routeLabelerProduct NDC
NitrofurantionNitrofurantoin 100 mg/1CapsuleOralA-S Medication Solutions50090-5693
NitrofurantionNitrofurantoin 25 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-231
NitrofurantionNitrofurantoin 50 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-232
NitrofurantionNitrofurantoin 100 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.57664-233
NitrofurantionNitrofurantoin 25 mg/1CapsuleOralBluePoint Labortories68001-384
NitrofurantionNitrofurantoin 50 mg/1CapsuleOralBluePoint Labortories68001-385
NitrofurantionNitrofurantoin 100 mg/1CapsuleOralBluePoint Labortories68001-386
NitrofurantionNitrofurantoin 100 mg/1CapsuleOralProficient Rx LP71205-171
NitrofurantionNitrofurantoin 100 mg/1CapsuleOralBryant Ranch Prepack71335-0024

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