Prescription drug · ANDA
Quinine Sulfate (Quinine) NDC 65162-811
Quinine sulfate 324 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-811-03 | 6516208110365162081103 | 30 CAPSULE in 1 BOTTLE (65162-811-03)Marketed from Jul 29, 2016 | |
| 65162-811-09 | 6516208110965162081109 | 90 CAPSULE in 1 BOTTLE (65162-811-09)Marketed from Jul 29, 2016 | |
| 65162-811-50 | 6516208115065162081150 | 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 LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203729
- Marketing start
- Listing expires
- 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
N465162081103followed by a unit qualifier and the quantityPackage 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 . 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.
About NDC 65162-811
- What is NDC 65162-811?
- 65162-811 is the product NDC for Quinine Sulfate (quinine), Quinine sulfate 324 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quinine Sulfate (Quinine).
- What is the active ingredient?
- Quinine sulfate.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quinine Sulfate?
- 3 other product NDCs are listed under this name. See all Quinine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quinine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Quinine Sulfate | Quinine sulfate 324 mg/1 | CapsuleOral | Ingenus Pharmaceuticals, LLC | 50742-238 | 50742-0238-30 |
| Quinine Sulfate | Quinine sulfate 324 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-560 | 68180-0560-06 |
| Quinine Sulfate | Quinine sulfate 324 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-3002 | 00093-3002-56 |