Prescription drug · ANDA
Quinine Sulfate NDC 0093-3002
Quinine sulfate 324 mg/1 · Capsule · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-3002-56 | 0009330025600093300256 | 30 CAPSULE in 1 BOTTLE (0093-3002-56)Marketed from Sep 28, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091661
- Marketing start
- Listing expires
- Identifiers
- Product ID 0093-3002_29ebf3c2-8351-43c3-82ac-3b118fb7faf6SPL ID 29ebf3c2-8351-43c3-82ac-3b118fb7faf6SPL set ID e782283e-2608-4fd6-a8b2-6c30b9d5d3b0RxCUI 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
N400093300256followed by a unit qualifier and the quantityPackage 00093-3002-56. 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 are 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 capsules are a antimalarial indicated for treatment of uncomplicated Plasmodium falciparum malaria. ( 1 ) Limitations of Use: Quinine sulfate capsules are not appr…
Excerpt only. Read the full label for complete information.
About NDC 0093-3002
- What is NDC 0093-3002?
- 0093-3002 is the product NDC for Quinine Sulfate, Quinine sulfate 324 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quinine Sulfate.
- What is the active ingredient?
- Quinine sulfate.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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 Sulfatequinine | Quinine sulfate 324 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-811 | 65162-0811-0365162-0811-0965162-0811-50 |
| Quinine Sulfate | Quinine sulfate 324 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-560 | 68180-0560-06 |