NDC codes

FDA NDC Directory
Product NDC (as listed)0555-0171Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00555-0171Add 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
0555-0171-780055501717825 BLISTER PACK in 1 CARTON (0555-0171-78) / 1 TABLET in 1 BLISTER PACK (0555-0171-88)Marketed from Jan 6, 2004

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)
Mefloquine Hydrochloride
Generic name (nonproprietary)
mefloquine hydrochloride
Active ingredients
Mefloquine hydrochloride — 250 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076392
Marketing start
Listing expires
Identifiers
Product ID 0555-0171_4b2b45f8-ed63-4b3c-87c5-801996f5b154SPL ID 4b2b45f8-ed63-4b3c-87c5-801996f5b154SPL set ID 09716a24-d7da-42b2-af29-c03a1b6670bdRxCUI 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

N400555017178 followed by a unit qualifier and the quantity

Package 00555-0171-78. 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 0555-0171

What is NDC 0555-0171?
0555-0171 is the product NDC for Mefloquine Hydrochloride, Mefloquine hydrochloride 250 mg/1 tablet, 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?
Mefloquine Hydrochloride.
What is the active ingredient?
Mefloquine hydrochloride.
Who is the labeler?
Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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/1TabletOralA-S Medication Solutions50090-239650090-2396-00

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/1TabletOralA-S Medication Solutions50090-2396

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