Montelukast Sodium
- Product NDC
- 70518-0172
- 11-digit product format
- 705180172
- Labeler code
- 70518
- Product ID
- 70518-0172_df5d4341-9c06-1367-e053-2a95a90a2ad4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA202717
- Marketing category
- ANDA
- Marketing start
- 2017-01-23
- 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-0172-0 | 70518017200 | 90 TABLET, FILM COATED in 1 BOTTLE (70518-0172-0) | 2017-01-23 | 0000-00-00 | No | No | Current |
| 70518-0172-1 | 70518017201 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0172-1) | 2017-10-10 | 0000-00-00 | No | No | Current |