NDC codes

FDA NDC Directory
Product NDC (as listed)0093-3002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-3002Add 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 NDC11-digit (billing)PackageCopy
0093-3002-56000933002560009330025630 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

N400093300256 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Quinine Sulfate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Quinine SulfateQuinine sulfate 324 mg/1CapsuleOralIngenus Pharmaceuticals, LLC50742-23850742-0238-30
Quinine SulfatequinineQuinine sulfate 324 mg/1CapsuleOralAmneal Pharmaceuticals LLC65162-81165162-0811-0365162-0811-0965162-0811-50
Quinine SulfateQuinine sulfate 324 mg/1CapsuleOralLupin Pharmaceuticals, Inc.68180-56068180-0560-06

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