Montelukast Sodium
- Product NDC
- 66116-503
- 11-digit product format
- 661160503
- Labeler code
- 66116
- Product ID
- 66116-503_b24549cf-6c14-4e49-8756-5bd6d88ec6b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- MedVantx, Inc.
- Application
- ANDA078605
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- Marketing end
- 0000-00-00
- Substance
- MONTELUKAST SODIUM
- Active strength
- 10 mg/1
- Pharmacologic classes
- Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66116-503-30 | Montelukast Sodium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MONTELUKAST SODIUM | ACTIVE INGREDIENT | U1O3J18SFL | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| MONTELUKAST | ACTIVE MOIETY | MHM278SD3E | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66116-503 | MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.] | 1 | Legacy NDC, 1 package rows | 20130409_b24549cf-6c14-4e49-8756-5bd6d88ec6b8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 66116-503-30 | 66116050330 | 30 in 1 BOTTLE | Historical |