Montelukast Sodium
- Product NDC
- 63187-289
- 11-digit product format
- 631870289
- Labeler code
- 63187
- Product ID
- 63187-289_f4f92f5f-7bae-4b32-91c0-a0394ac8502b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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
- 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 |
|---|
| MONTELUKAST SODIUM | ACTIVE INGREDIENT | U1O3J18SFL | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| MONTELUKAST | ACTIVE MOIETY | MHM278SD3E | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-289 | MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP] | 3 | Legacy NDC | 20210116_b08de8f6-f755-49ea-88c8-5c22b0cdbc4c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-289-30 | 63187028930 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-289-30) | 2019-01-01 | 0000-00-00 | No | No | Current |