montelukast sodium
- Product NDC
- 33261-969
- 11-digit product format
- 332610969
- Labeler code
- 33261
- Product ID
- 33261-969_733ee823-ddd2-45b5-9d27-44105e5bf34c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA090926
- 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
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 33261-969-30 | montelukast sodium | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 33261-969-90 | montelukast sodium | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 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 [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MONTELUKAST | ACTIVE MOIETY | MHM278SD3E | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSE 2910 (15000 MPA.S) | INACTIVE INGREDIENT | 288VBX44JC | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33261-969 | MONTELUKAST SODIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 2 package rows | 20140128_f3f3ee81-2530-402f-9c0a-c828fda2ca1f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33261-969-30 | 33261096930 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 33261-969-90 | 33261096990 | 90 in 1 BOTTLE, PLASTIC | Historical |