montelukast sodium
- Product NDC
- 69844-076
- 11-digit product format
- 698440076
- Labeler code
- 69844
- Product ID
- 69844-076_d32e1626-8663-4fb2-8c21-d3df59cd61db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Graviti Pharmaceuticals Private Limited
- Application
- ANDA209012
- Marketing category
- ANDA
- Marketing start
- 2022-01-21
- 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
- 2023-12-31
- 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 |
|---|
| 69844-076-01 | 69844007601 | 30 TABLET in 1 BOTTLE (69844-076-01) | 30 tablet | 2022-01-21 | 0000-00-00 | No | No | Current |
| 69844-076-02 | 69844007602 | 90 TABLET in 1 BOTTLE (69844-076-02) | 90 tablet | 2022-01-21 | 0000-00-00 | No | No | Current |