Mefloquine Hydrochloride
- Product NDC
- 0054-0025
- 11-digit product format
- 000540025
- Labeler code
- 0054
- Product ID
- 0054-0025_e6ca0066-8671-4719-8707-90b4121cba11
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mefloquine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA076523
- Marketing category
- ANDA
- Marketing start
- 2004-10-01
- Marketing end
- 0000-00-00
- Substance
- MEFLOQUINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Antimalarial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MEFLOQUINE HYDROCHLORIDE | ACTIVE INGREDIENT | 5Y9L3636O3 | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
| MEFLOQUINE | ACTIVE MOIETY | TML814419R | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
| CALCIUM ALGINATE | INACTIVE INGREDIENT | 8P20S56HZI | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
| POLOXAMER 331 | INACTIVE INGREDIENT | IS93EQR73R | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
| PROPYLENE GLYCOL ALGINATE | INACTIVE INGREDIENT | 26CD3J2R0C | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MEFLOQUINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0025 | MEFLOQUINE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.] | 14 | Legacy NDC | 20210819_43fde257-36ee-49ea-a03c-01a1a4e1da3d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0025-11 | 00054002511 | 1 BOTTLE in 1 CARTON (0054-0025-11) > 25 TABLET in 1 BOTTLE | 1 bottle | 2004-10-01 | 0000-00-00 | No | No | Current |