SINGULAIR
- Product NDC
- 21695-565
- 11-digit product format
- 216950565
- Labeler code
- 21695
- Product ID
- 21695-565_78eea56d-15a6-4ceb-b755-d1a3e9707f32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA020830
- Marketing category
- NDA
- Marketing start
- 1998-02-20
- Marketing end
- 0000-00-00
- Substance
- MONTELUKAST SODIUM
- Active strength
- 5 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8d8a355b-240d-8c38-7331-c9e3c1068a33 | Product name | 9 | 20161220 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-565-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b57-48b1-e053-8cdaa90a720a | These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR ® (montelukast sodium) tablets, chewable tablets, and oral granules Initial U.S. Approval: 1998 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-565-30 | SINGULAIR | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 21695-565 | SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20101210_78eea56d-15a6-4ceb-b755-d1a3e9707f32.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 200224 | montelukast sodium 10 MG Oral Tablet | PSN | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 242438 | montelukast sodium 5 MG Chewable Tablet | PSN | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 153892 | Singulair 10 MG Oral Tablet | PSN | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 153893 | Singulair 5 MG Chewable Tablet | PSN | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 153892 | montelukast 10 MG Oral Tablet [Singulair] | SBD | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 153893 | montelukast 5 MG Chewable Tablet [Singulair] | SBD | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 200224 | montelukast 10 MG Oral Tablet | SCD | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 242438 | montelukast 5 MG Chewable Tablet | SCD | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 200224 | montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet | SY | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 242438 | montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet | SY | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 153892 | Singulair 10 MG (montelukast sodium 10.4 MG) Oral Tablet | SY | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 153892 | Singulair 10 MG Oral Tablet | SY | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 153893 | Singulair 5 MG (montelukast sodium 5.2 MG) Chewable Tablet | SY | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
| 153893 | Singulair 5 MG Chewable Tablet | SY | 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-565-30 | 21695056530 | 30 in 1 BOTTLE | Historical |