Montelukast Sodium
- Product NDC
- 63629-4855
- 11-digit product format
- 636294855
- Labeler code
- 63629
- Product ID
- 63629-4855_3489a7de-e6b4-4c7c-8837-958d692a29bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA201508
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 63629-4855 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 63629-4855 | 63629-4855-1 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 63629-4855 | 63629-4855-2 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 63629-4855 | 63629-4855-3 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A201508-001 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | | | 2012-08-03 |
| A201508-002 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | | | 2012-08-03 |
FDA-Initiated Inactive NDC Indexing#