NDC 68788-7669-02 - montelukast sodium
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68788-7669
- Requested NDC
- 68788-7669-02
- Package NDCs from labels
- 68788-7669-1, 68788-7669-4, 68788-7669-2, 68788-7669-3, 68788-7669-6, 68788-7669-9, 68788-7669-02
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Effective date
- 2026-01-13
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| montelukast sodium - Preferred Pharmaceuticals, Inc. | Preferred Pharmaceuticals, Inc. | 2026-01-13 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-7669-1 | montelukast sodium | 10 in 1 BOTTLE | TABLET, CHEWABLE | 10 | 6 | |
| 68788-7669-2 | montelukast sodium | 20 in 1 BOTTLE | TABLET, CHEWABLE | 20 | 6 | |
| 68788-7669-3 | montelukast sodium | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 6 | |
| 68788-7669-4 | montelukast sodium | 14 in 1 BOTTLE | TABLET, CHEWABLE | 14 | 6 | |
| 68788-7669-6 | montelukast sodium | 60 in 1 BOTTLE | TABLET, CHEWABLE | 60 | 6 | |
| 68788-7669-9 | montelukast sodium | 90 in 1 BOTTLE | TABLET, CHEWABLE | 90 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-7669 | MONTELUKAST SODIUM TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20240724_09b0bc9e-3035-45b4-b61b-4aca70848360.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7669-1 | EA - Each | 68788-7669 | d130ce6b-a2ca-45d0-a0a8-17e7747895cc | 1 | 2020-05-08 |
| 68788-7669-2 | EA - Each | 68788-7669 | 7464d2ce-011e-4809-8c93-bd9002fb3eb9 | 1 | 2020-05-08 |
| 68788-7669-3 | EA - Each | 68788-7669 | 7f8181e8-7f69-4d34-a1cb-390fe7cba86b | 1 | 2020-05-08 |
| 68788-7669-4 | EA - Each | 68788-7669 | 6fced204-8cfd-4b4a-9661-6e6b836bf866 | 1 | 2020-05-08 |
| 68788-7669-6 | EA - Each | 68788-7669 | 55367211-9966-44f2-a1cb-1b734d894007 | 1 | 2020-05-08 |
| 68788-7669-9 | EA - Each | 68788-7669 | 53c0e2ee-c978-4e3c-880d-1dd89588f570 | 1 | 2020-05-08 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Calamine | CALAMINE, PRAMOXINE HCL | United Natural Foods, Inc. dba UNFI | 0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea | 2026-09-04 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | Your Military Exchanges | af95a66c-f063-4019-80c6-6f7dc4fee4d8 | 2026-08-28 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine Plus | CALAMINE, PRAMOXINE HYDROCHLORIDE | Kroger Company | 44fdd5a4-3cac-15e5-e063-6294a90adb52 | 2026-08-26 | Warnings | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | The Kroger Co. | 9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308 | 2026-08-06 | Warnings, Adverse reactions | 1K09F3G675 |
| Montelukast Sodium | MONTELUKAST SODIUM | Torrent Pharmaceuticals Limited | da038cf6-cfad-43a4-ab8e-d81d028d6087 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 311759 242438 |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 57110309-9a3d-025f-e063-6394a90a015a | 2026-07-22 | Warnings | 1K09F3G675 |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 571083ce-cd35-a638-e063-6394a90ae4c7 | 2026-07-20 | Warnings | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | Better Living Brands, LLC | c7ef0ef3-6861-4b94-af4b-371fee8c1f3d | 2026-07-16 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | Target Corporation | 36602b7a-99c0-f6a4-e063-6294a90a8758 | 2026-06-29 | Warnings | 1K09F3G675 |
| CalaSoothe | CALAMINE, MENTHOL, AND ZINC OXIDE | Dynarex Corporation | 54f12005-acfe-4821-e063-6394a90ac304 | 2026-06-24 | Warnings | 1K09F3G675 |
| Calamine, Pramoxind HCl | CALAMINE, PRAMOXIND HCL | H E B | 4a7a0b09-d9bc-e752-e063-6394a90a9f2c | 2026-06-15 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine, Zinc Oxide | CALAMINE, ZINC OXIDE | H E B | 4a79259e-64ac-d187-e063-6294a90a78db | 2026-06-15 | Warnings, Adverse reactions | 1K09F3G675 |
| Montelukast Sodium | MONTELUKAST SODIUM | Rising Pharma Holdings, Inc. | 49669ac0-0bb5-4576-bed5-9e85e0d76a44 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 311759 242438 |
| Calamine | CALAMINE AND ZINC OXIDE | Pharma Nobis, LLC | fbcfa541-beda-06de-e053-6294a90a9298 | 2026-05-26 | Warnings | 1K09F3G675 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | CVS Pharmacy | db6f518d-3a0e-43f8-8d19-7382d9b7ff1c | 2026-05-11 | Warnings | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | Retail Business Services, LLC | 7291e175-a9b6-4c47-93ce-227ce11e4599 | 2026-04-30 | Warnings, Adverse reactions | 1K09F3G675 |
| Mannitol | MANNITOL | Hospira, Inc. | 8ad3145e-00e7-4412-b9a5-06f00f264f30 | 2026-04-21 | Warnings, Adverse reactions | 3OWL53L36A |
| Calamine | CALAMINE 8%, ZINC OXIDE 8% | Farmacias De Similares TX LLC | 4ecd0add-11c9-cf3b-e063-6394a90adff6 | 2026-04-06 | Warnings | 1K09F3G675 |
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 4d3a0a92-b0de-a1ea-e063-6294a90a8508 | 2026-03-17 | Warnings | 1K09F3G675 |
| montelukast sodium | MONTELUKAST SODIUM | A-S Medication Solutions | 7ff11e37-9ea5-40b6-96f7-4caf27cab756 | 2026-03-07 | Boxed warning, Warnings, Adverse reactions | ANDA204093 242438 MHM278SD3E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.