MONTELUKAST SODIUM
- Product NDC
- 71335-0033
- 11-digit product format
- 713350033
- Labeler code
- 71335
- Product ID
- 71335-0033_1a6fb99a-9fec-47e9-aab2-7c433d35e1e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MONTELUKAST SODIUM
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203328
- Marketing category
- ANDA
- Marketing start
- 2015-08-13
- Marketing end
- 0000-00-00
- Substance
- MONTELUKAST SODIUM
- Active strength
- 4 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 |
|---|
| 71335-0033-1 | 71335003301 | 30 TABLET, CHEWABLE in 1 BOTTLE (71335-0033-1) | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0033-2 | 71335003302 | 90 TABLET, CHEWABLE in 1 BOTTLE (71335-0033-2) | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0033-3 | 71335003303 | 60 TABLET, CHEWABLE in 1 BOTTLE (71335-0033-3) | 2021-12-27 | 0000-00-00 | No | No | Current |