Montelukast
- Product NDC
- 0781-5554
- 11-digit product format
- 007815554
- Labeler code
- 0781
- Product ID
- 0781-5554_b0e6f41c-217f-4203-a8dc-ecd2bceb069f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA091414
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0781-5554-05 | 00781555405 | 500 TABLET, CHEWABLE in 1 BOTTLE (0781-5554-05) | | 2012-08-03 | 0000-00-00 | No | No | Current |
| 0781-5554-13 | 00781555413 | 10 BLISTER PACK in 1 CARTON (0781-5554-13) > 10 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5554-06) | 10 blister pack | 2012-08-03 | 0000-00-00 | No | No | Current |
| 0781-5554-31 | 00781555431 | 30 TABLET, CHEWABLE in 1 BOTTLE (0781-5554-31) | | 2012-08-03 | 0000-00-00 | No | No | Current |
| 0781-5554-64 | 00781555464 | 3 BLISTER PACK in 1 CARTON (0781-5554-64) > 10 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5554-06) | 3 blister pack | 2012-08-03 | 0000-00-00 | No | No | Current |
| 0781-5554-92 | 00781555492 | 90 TABLET, CHEWABLE in 1 BOTTLE (0781-5554-92) | | 2012-08-03 | 0000-00-00 | No | No | Current |