Montelukast
- Product NDC
- 68645-560
- 11-digit product format
- 686450560
- Labeler code
- 68645
- Product ID
- 68645-560_ce3ec6fb-44f3-3acd-e053-2995a90abd2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA202843
- Marketing category
- ANDA
- Marketing start
- 2014-09-10
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68645-560 | MONTELUKAST TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 8 | Legacy NDC | 20241016_b7182fd7-c018-401d-ad24-c0a2cc8d1c58.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68645-560-54 | 68645056054 | 30 TABLET, FILM COATED in 1 BOTTLE (68645-560-54) | 2014-09-10 | 0000-00-00 | No | No | Current |