Montelukast Sodium
- Product NDC
- 68084-875
- 11-digit product format
- 680840875
- Labeler code
- 68084
- Product ID
- 68084-875_25c65159-60a2-629f-e063-6394a90a917f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA201582
- Marketing category
- ANDA
- Marketing start
- 2015-04-02
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Montelukast Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MONTELUKAST SODIUM | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U1O3J18SFL |
| Rxcui | 200224 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-875-01 | Montelukast Sodium | 100 in 1 BOX, UNIT-DOSE | TABLET, COATED | 100 | | 9 |
| 68084-875-11 | Montelukast Sodium | 1 in 1 BLISTER PACK | TABLET, COATED | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Montelukast Sodium | ACTIVE INGREDIENT | U1O3J18SFL | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| montelukast | ACTIVE MOIETY | MHM278SD3E | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| aspartame | INACTIVE INGREDIENT | Z0H242BBR1 | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| cherry | INACTIVE INGREDIENT | BUC5I9595W | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| Hydroxypropyl Cellulose (Type H) | INACTIVE INGREDIENT | RFW2ET671P | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-875 | MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241102_fb1b2e4e-a840-447b-b943-ad0b6acc32b5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-875-01 | 68084087501 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-875-01) / 1 TABLET, COATED in 1 BLISTER PACK (68084-875-11) | 100 blister pack | 2015-04-02 | 0000-00-00 | No | No | Current |
| 68084-875-11 | 68084087511 | 1 in 1 BLISTER PACK | | | | | | Historical |