NDC codes

FDA NDC Directory
Product NDC (as listed)51407-869Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0869Add 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
51407-869-015140708690151407086901100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-01)Marketed from Apr 2, 2024
51407-869-24514070869245140708692424 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-24)Marketed from Apr 2, 2024

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

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
Golden State Medical Supply, Inc.NDC labeler code 51407
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202362
Marketing start
Listing expires
Other FDA classes
Dihydrofolate Reductase Inhibitors (Mechanism)
Identifiers
Product ID 51407-869_45b153c9-e06e-468c-e063-6294a90a2938SPL ID 45b153c9-e06e-468c-e063-6294a90a2938SPL set ID 152433eb-1341-9cc0-e063-6394a90a1481RxCUI 864675UNII Y883P1Z2LT, R71Y86M0WT
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

N451407086901 followed by a unit qualifier and the quantity

Package 51407-0869-01. 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 .

Indications (excerpt from the label)

Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. ( 1.1 ) treatment of acute, uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride tablets have been shown to be effe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51407-869

What is NDC 51407-869?
51407-869 is the product NDC for Atovaquone and Proguanil Hydrochloride, Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Golden State Medical Supply, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Atovaquone and Proguanil Hydrochloride.
What is the active ingredient?
Atovaquone, Proguanil hydrochloride.
Who is the labeler?
Golden State Medical Supply, Inc., NDC labeler code 51407. 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 Hydrochloride?
7 other product NDCs are listed under this name. See all Atovaquone and Proguanil Hydrochloride 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 Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Atovaquone and Proguanil HydrochlorideAtovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-416000378-4160-01
Atovaquone and Proguanil HydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-416200378-4162-01
Atovaquone and Proguanil HydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-24568001-0245-0068001-0245-15
Atovaquone and Proguanil HydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-130250090-1302-0050090-1302-0150090-1302-02+6 more
Atovaquone and Proguanil HydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc.,USA68462-40468462-0404-0168462-0404-67
Atovaquone and Proguanil HydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-316071335-3160-0171335-3160-0271335-3160-03+2 more
Atovaquone and Proguanil HydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralProficient Rx LP63187-87963187-0879-1663187-0879-24

Other NDCs under ANDA 202362

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

FDA NDC Directory listings under ANDA 202362
ProductStrengthForm · routeLabelerProduct NDC
Atovaquone and Proguanil HydrochlorideAtovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-4160
Atovaquone and Proguanil HydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-4162

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