Montelukast
- Product NDC
- 70518-2603
- 11-digit product format
- 705182603
- Labeler code
- 70518
- Product ID
- 70518-2603_caccb645-a2dc-6141-e053-2a95a90af83f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203366
- Marketing category
- ANDA
- Marketing start
- 2020-02-27
- 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
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2603-0 | 70518260300 | 30 TABLET in 1 BLISTER PACK (70518-2603-0) | 30 tablet | 2020-02-27 | 0000-00-00 | No | No | Current |
| 70518-2603-1 | 70518260301 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-2603-1) | 90 tablet | 2020-03-24 | 0000-00-00 | No | No | Current |
| 70518-2603-2 | 70518260302 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-2603-2) | 30 tablet | 2020-06-30 | 0000-00-00 | No | No | Current |