Prescription drug · ANDA
Quinine Sulfate NDC 68180-560
Quinine sulfate 324 mg/1 · Capsule · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-560-06 | 68180056006 | 30 CAPSULE in 1 BOTTLE (68180-560-06)Marketed from Aug 4, 2015 |
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 sulfate
- Active ingredients
- Quinine sulfate — 324 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203112
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-560_8cd4d427-50ac-4f9c-a029-e7c2d063679aSPL ID 8cd4d427-50ac-4f9c-a029-e7c2d063679aSPL set ID 1f32f05c-a215-40be-b951-e41a7b54a8a0RxCUI 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
N468180056006followed by a unit qualifier and the quantityPackage 68180-0560-06. 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 capsule USP is a cinchona alkaloid indicated for treatment of uncomplicated Plasmodium falciparum malaria ( 1 ). Quinine sulfate capsule USP 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 )] . Quinine sulfate capsules USP 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 )] .
Excerpt only. Read the full label for complete information.