Quinine Sulfate (quinine) NDC 65162-811

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-811Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0811Add 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
65162-811-03	65162081103	30 CAPSULE in 1 BOTTLE (65162-811-03)Marketed from Jul 29, 2016
65162-811-09	65162081109	90 CAPSULE in 1 BOTTLE (65162-811-09)Marketed from Jul 29, 2016
65162-811-50	65162081150	500 CAPSULE in 1 BOTTLE (65162-811-50)Marketed from Jul 29, 2016

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): Quinine Sulfate
Generic name (nonproprietary): quinine
Active ingredients: Quinine sulfate — 324 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203729
Marketing start: Jul 29, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 65162-811_b1b6d20f-5e99-4205-9f40-fa4a8af3416dSPL ID b1b6d20f-5e99-4205-9f40-fa4a8af3416dSPL set ID f567d5c7-ea5d-49a7-a035-b47208135f73RxCUI 997010UNII KF7Z0E0Q2B
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

N465162081103 followed by a unit qualifier and the quantity

Package 65162-0811-03. 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 Dec 9, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Quinine sulfate is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14) ] . Limitations of Use: Quinine sulfate capsules are not approved for: Treatment of severe or complicated P. falciparum malaria. Prevention of malaria. Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1) ] . Quinine sulfate is an antimalarial indicated for treatment of uncomplicated Plasmodium falciparum malaria. (1) Limitations of Use: Quinine sulfate capsules are not approved for: Treatment of se…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)