Montelukast Sodium
- Product NDC
- 0093-7424
- 11-digit product format
- 000937424
- Labeler code
- 0093
- Product ID
- 0093-7424_7d53adbd-8c7e-4e6b-b310-353dd087fac3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA078723
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- Marketing end
- 2021-05-31
- Substance
- MONTELUKAST SODIUM
- Active strength
- 4 mg/1
- Pharmacologic classes
- Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MONTELUKAST SODIUM | ACTIVE INGREDIENT | U1O3J18SFL | MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 4 | |
| MONTELUKAST | ACTIVE MOIETY | MHM278SD3E | MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 4 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 4 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 4 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 4 | |
| MONTELUKAST SODIUM | ACTIVE INGREDIENT | U1O3J18SFL | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MONTELUKAST | ACTIVE MOIETY | MHM278SD3E | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-7424-56 | 00093742456 | 30 TABLET, CHEWABLE in 1 BOTTLE (0093-7424-56) | 2012-08-03 | 2021-05-31 | No | No | Current |
| 0093-7424-98 | 00093742498 | 90 TABLET, CHEWABLE in 1 BOTTLE (0093-7424-98) | 2012-08-03 | 2021-05-31 | No | No | Current |