Prescription drug · ANDA
Mefloquine Hydrochloride NDC 0555-0171
Mefloquine hydrochloride 250 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-0171-78 | 00555017178 | 25 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
N400555017178followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Mefloquine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mefloquine Hydrochloride | Mefloquine hydrochloride 250 mg/1 | TabletOral | Chartwell RX, LLC | 62135-973 | 62135-0973-1162135-0973-25 |
| Mefloquine Hydrochloride | Mefloquine hydrochloride 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-2396 | 50090-2396-00 |
Other NDCs under ANDA 076392
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Mefloquine Hydrochloride | Mefloquine hydrochloride 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-2396 |