Prescription drug · ANDA
Chloroquine Phosphate NDC 42291-047
Chloroquine phosphate 500 mg/1 · Tablet · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-047-25 | 42291004725 | 25 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
N442291004725followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Chloroquine Phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Chloroquine Phosphate | Chloroquine phosphate 500 mg/1 | Tablet, CoatedOral | Chartwell RX, LLC | 62135-717 | 62135-0717-26 |
| Chloroquine Phosphate | Chloroquine phosphate 500 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-7010 | 00115-7010-0100115-7010-0200115-7010-09 |
| Chloroquine Phosphate | Chloroquine phosphate 250 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-2790 | 00115-2790-0200115-2790-06 |
| Chloroquine Phosphate | Chloroquine phosphate 500 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-178 | 64980-0178-0164980-0178-0264980-0178-05+1 more |
| Chloroquine Phosphate | Chloroquine phosphate 250 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-177 | 64980-0177-0164980-0177-0564980-0177-10+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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Chloroquine Phosphate | Chloroquine phosphate 500 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-7010 |