NDC codes

FDA NDC Directory
Product NDC (as listed)42291-047Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42291-0047Add 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
42291-047-254229100472525 TABLET in 1 BOTTLE (42291-047-25)Marketed from Nov 15, 2023

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)
Chloroquine Phosphate
Generic name (nonproprietary)
chloroquine phosphate
Active ingredients
Chloroquine phosphate — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
AvKARENDC labeler code 42291
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040516
Marketing start
Listing expires
Identifiers
Product ID 42291-047_484c12cb-6b66-1ca6-e063-6394a90a7cfbSPL ID 484c12cb-6b66-1ca6-e063-6394a90a7cfbSPL set ID 0a342f72-45f9-3e12-e063-6394a90ae33eRxCUI 1116758UNII 6E17K3343P
Pharmacologic class
Antimalarial

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

N442291004725 followed by a unit qualifier and the quantity

Package 42291-0047-25. 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 Chloroquine phosphate tablets are indicated for the: Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale , and P.vivax. Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present. Treatment of extraintestinal amebiasis. Chloroquine phosphate tablets do not prevent relapses in patients with vivax or ovale malaria because it is not effective against exoerythrocytic forms of the parasites. Limitations of Use in Malaria: Do not use chloroquine phosphate tablets for the treatment of complicated malaria (high-grade parasitemia and/or complications e.g., cerebral malaria or acute renal failure). Do…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-047

What is NDC 42291-047?
42291-047 is the product NDC for Chloroquine Phosphate, Chloroquine phosphate 500 mg/1 tablet, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Chloroquine Phosphate.
What is the active ingredient?
Chloroquine phosphate.
Who is the labeler?
AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Chloroquine Phosphate?
5 other product NDCs are listed under this name. See all Chloroquine Phosphate 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 Chloroquine Phosphate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Chloroquine PhosphateChloroquine phosphate 500 mg/1Tablet, CoatedOralChartwell RX, LLC62135-71762135-0717-26
Chloroquine PhosphateChloroquine phosphate 500 mg/1TabletOralAmneal Pharmaceuticals of New York LLC0115-701000115-7010-0100115-7010-0200115-7010-09
Chloroquine PhosphateChloroquine phosphate 250 mg/1TabletOralAmneal Pharmaceuticals of New York LLC0115-279000115-2790-0200115-2790-06
Chloroquine PhosphateChloroquine phosphate 500 mg/1TabletOralRising Pharma Holdings, Inc.64980-17864980-0178-0164980-0178-0264980-0178-05+1 more
Chloroquine PhosphateChloroquine phosphate 250 mg/1TabletOralRising Pharma Holdings, Inc.64980-17764980-0177-0164980-0177-0564980-0177-10+1 more

Other NDCs under ANDA 040516

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

FDA NDC Directory listings under ANDA 040516
ProductStrengthForm · routeLabelerProduct NDC
Chloroquine PhosphateChloroquine phosphate 500 mg/1TabletOralAmneal Pharmaceuticals of New York LLC0115-7010

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