Prescription drug · ANDA
Quinine Sulfate NDC 50742-238
Quinine sulfate 324 mg/1 · Capsule · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-238-30 | 50742023830 | 30 CAPSULE in 1 BOTTLE, PLASTIC (50742-238-30)Marketed from Dec 11, 2017 |
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
- Ingenus Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204372
- Marketing start
- Listing expires
- Identifiers
- Product ID 50742-238_0a0b38d3-828f-4828-8d8c-92933872aa4fSPL ID 0a0b38d3-828f-4828-8d8c-92933872aa4fSPL set ID b2f73c64-b92c-49bf-ad39-e32ac83e4d3dRxCUI 997010UNII KF7Z0E0Q2BUPC 0350742238309
- 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
N450742023830followed by a unit qualifier and the quantityPackage 50742-0238-30. 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 Capsules, 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 )]. Limitations of Use: Quinine Sulfate is 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 Capsules, USP is an antimalarial indicated for treatment of uncomplicated Plasmodium falciparum malaria. ( 1 ) Limitations of Use: Quinine Sulfate is not approved for: Treat…
Excerpt only. Read the full label for complete information.