NDC codes

FDA NDC Directory
Product NDC (as listed)50090-2396Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-2396Add 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
50090-2396-0500902396001 BLISTER PACK in 1 CARTON (50090-2396-0) / 10 TABLET in 1 BLISTER PACKMarketed from May 6, 2016

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

Brand name (proprietary)
Mefloquine Hydrochloride
Generic name (nonproprietary)
mefloquine hydrochloride
Active ingredients
Mefloquine hydrochloride — 250 mg/1
Dosage form
Tablet
Route
Oral
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076392
Marketing start
Listing expires
Identifiers
Product ID 50090-2396_4c4467e1-5886-4b66-aaff-8647a8591fceSPL ID 4c4467e1-5886-4b66-aaff-8647a8591fceSPL set ID 9cbe26c7-7313-4cd6-9514-9190af1de763RxCUI 835913UNII 5Y9L3636O3
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

N450090239600 followed by a unit qualifier and the quantity

Package 50090-2396-00. 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

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Treatment of Acute Malaria Infections Mefloquine Hydrochloride Tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequent…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-2396

What is NDC 50090-2396?
50090-2396 is the product NDC for Mefloquine Hydrochloride, Mefloquine hydrochloride 250 mg/1 tablet, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mefloquine Hydrochloride.
What is the active ingredient?
Mefloquine 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 Mefloquine Hydrochloride?
2 other product NDCs are listed under this name. See all Mefloquine 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 Mefloquine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Mefloquine HydrochlorideMefloquine hydrochloride 250 mg/1TabletOralChartwell RX, LLC62135-97362135-0973-1162135-0973-25
Mefloquine HydrochlorideMefloquine hydrochloride 250 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0555-017100555-0171-78

Other NDCs under ANDA 076392

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

FDA NDC Directory listings under ANDA 076392
ProductStrengthForm · routeLabelerProduct NDC
Mefloquine HydrochlorideMefloquine hydrochloride 250 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0555-0171

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