Montelukast
- Product NDC
- 68071-2425
- 11-digit product format
- 680712425
- Labeler code
- 68071
- Product ID
- 68071-2425_c3660653-6f3e-37a8-e053-2995a90afa1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2425 | MONTELUKAST TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 1 | Legacy NDC | 20210529_c36601b4-bc82-f077-e053-2995a90a7b8b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2425-9 | 68071242509 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-2425-9) | 2021-05-28 | 0000-00-00 | No | No | Current |