NDC codes

FDA NDC Directory
Product NDC (as listed)66993-060Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66993-0060Add 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
66993-060-026699300600266993006002100 TABLET, FILM COATED in 1 BOTTLE (66993-060-02)Marketed from Jul 27, 2012
66993-060-27669930060276699300602724 TABLET, FILM COATED in 1 DOSE PACK (66993-060-27)Marketed from Jul 27, 2012

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)
Atovaquone and Proguanil HCl
Generic name (nonproprietary)
atovaquone and proguanil hydrochloride
Active ingredients
Atovaquone — 250 mg/1Proguanil hydrochloride — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Prasco LaboratoriesNDC labeler code 66993
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021078
Marketing start
Listing expires
Other FDA classes
Dihydrofolate Reductase Inhibitors (Mechanism)
Identifiers
Product ID 66993-060_c61a1c15-bfa3-46f1-a4b1-388bbd34d7d5SPL ID c61a1c15-bfa3-46f1-a4b1-388bbd34d7d5
Pharmacologic class
Antimalarial; Antiprotozoal

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

N466993006002 followed by a unit qualifier and the quantity

Package 66993-0060-02. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 66993-060

What is NDC 66993-060?
66993-060 is the product NDC for Atovaquone and Proguanil HCl, Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Prasco Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Atovaquone and Proguanil HCl (Atovaquone and proguanil hydrochloride).
What is the active ingredient?
Atovaquone, Proguanil hydrochloride.
Who is the labeler?
Prasco Laboratories, NDC labeler code 66993. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Atovaquone and Proguanil HCl?
1 other product NDC are listed under this name. See all Atovaquone and Proguanil HCl 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 Atovaquone and Proguanil HCl NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Atovaquone and Proguanil HClatovaquone and proguanil hydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-298050090-2980-0050090-2980-0150090-2980-02+7 more

Other NDCs under NDA 021078

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021078
ProductStrengthForm · routeLabelerProduct NDC
Atovaquone and Proguanil HClatovaquone and proguanil hydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2980
Malaroneatovaquone and proguanil hydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralGlaxoSmithKline LLC0173-0675
Malaroneatovaquone and proguanil hydrochlorideAtovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1Tablet, Film coatedOralGlaxoSmithKline LLC0173-0676

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