NDC codes

FDA NDC Directory
Product NDC (as listed)50090-1302Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-1302Add 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
50090-1302-050090130200500901302007 TABLET, FILM COATED in 1 BOTTLE (50090-1302-0)Marketed from Nov 28, 2014
50090-1302-1500901302015009013020112 TABLET, FILM COATED in 1 BOTTLE (50090-1302-1)Marketed from Nov 28, 2014
50090-1302-2500901302025009013020214 TABLET, FILM COATED in 1 BOTTLE (50090-1302-2)Marketed from Nov 28, 2014
50090-1302-3500901302035009013020316 TABLET, FILM COATED in 1 BOTTLE (50090-1302-3)Marketed from Nov 28, 2014
50090-1302-4500901302045009013020424 TABLET, FILM COATED in 1 BOTTLE (50090-1302-4)Marketed from Nov 28, 2014
50090-1302-550090130205500901302055 TABLET, FILM COATED in 1 BOTTLE (50090-1302-5)Marketed from Nov 28, 2014
50090-1302-6500901302065009013020610 TABLET, FILM COATED in 1 BOTTLE (50090-1302-6)Marketed from Nov 28, 2014
50090-1302-8500901302085009013020820 TABLET, FILM COATED in 1 BOTTLE (50090-1302-8)Marketed from Sep 29, 2017
50090-1302-9500901302095009013020930 TABLET, FILM COATED in 1 BOTTLE (50090-1302-9)Marketed from Sep 28, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091211
Marketing start
Listing expires
Other FDA classes
Dihydrofolate Reductase Inhibitors (Mechanism)
Identifiers
Product ID 50090-1302_0f4d7baa-42e4-4375-ab9b-97f96eebb3feSPL ID 0f4d7baa-42e4-4375-ab9b-97f96eebb3fe
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

N450090130200 followed by a unit qualifier and the quantity

Package 50090-1302-00. 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 50090-1302

What is NDC 50090-1302?
50090-1302 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 A-S Medication Solutions. It has 9 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?
A-S Medication Solutions, NDC labeler code 50090. 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 coatedOralGolden State Medical Supply, Inc.51407-86951407-0869-0151407-0869-24
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 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 091211

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

FDA NDC Directory listings under ANDA 091211
ProductStrengthForm · routeLabelerProduct NDC
Atovaquone and Proguanil HydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralProficient Rx LP63187-879
Atovaquone and Proguanil HydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-245
Atovaquone and Proguanil HydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc.,USA68462-404
Atovaquone and Proguanil HydrochlorideAtovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3160
Atovaquone and Proguanil Hydrochloride PediatricAtovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc.,USA68462-402

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