NDC 68788-7669-01 - 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
- 68788-7669-01
- Package NDCs from labels
- 68788-7669-1, 68788-7669-4, 68788-7669-2, 68788-7669-3, 68788-7669-6, 68788-7669-9, 68788-7669-01
- 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 |
|---|---|---|---|---|---|---|
| Aveeno Anti-Itch Concentrated | ZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 07f4d4d0-9cee-46c3-bc71-2024abd31c9e | 2025-10-29 | Warnings | 1K09F3G675 |
| Montelukast Sodium | MONTELUKAST SODIUM | AvPAK | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 2025-10-29 | Warnings, Adverse reactions | 311759 242438 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | Premier Brands of America, Inc. | d3452573-f91f-f157-e053-2a95a90a1ad8 | 2025-10-27 | Warnings | 1K09F3G675 |
| Mannitol | MANNITOL | ICU Medical Inc. | ba7bf864-8a4d-4262-8fd1-00174fa2f9d1 | 2025-10-24 | Warnings, Adverse reactions | 3OWL53L36A |
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 08b52f29-c1a0-c673-e063-6294a90a9a7a | 2025-09-05 | Warnings | 1K09F3G675 |
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 08b8003f-40be-3380-e063-6294a90a4f6b | 2025-09-05 | Warnings | 1K09F3G675 |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Ajanta Pharma USA Inc. | 67070e4e-f755-46b3-b900-fcc1993a0546 | 2025-08-29 | Boxed warning, Warnings, Adverse reactions | 311759 242438 |
| Osmitrol | MANNITOL | Baxter Healthcare Company | 0d914965-7001-45cb-ba51-d7c5964b05bc | 2025-08-26 | Warnings, Adverse reactions | 3OWL53L36A |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | FSA Store Inc. | 3cd18f96-34f7-3f2c-e063-6294a90a3b7e | 2025-08-19 | Warnings | 1K09F3G675 |
| Ferrum rosatum Graphites | FERRUM ROSATUM GRAPHITES | Uriel Pharmacy Inc. | 1a4ca338-eada-4c0f-8bce-480244940c89 | 2025-06-27 | Warnings | 1K09F3G675 |
| Aquavit | AQUAVIT | Uriel Pharmacy Inc. | c1c0887a-c388-c737-e053-2a95a90a076c | 2025-06-06 | Warnings | 1K09F3G675 |
| Insecticides/Pest/Food Additives Detox | BOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Dr. Donna Restivo DC | b5778211-0e3e-44ef-bd65-a76a68cf1504 | 2025-05-23 | Warnings | Z0H242BBR1 |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | 3OWL53L36A |
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 08b7eeeb-09ae-ffe6-e063-6294a90aba90 | 2025-05-07 | Warnings | 1K09F3G675 |
| SINGULAIR | MONTELUKAST SODIUM | Organon LLC | 482dcc92-b47f-4ea6-854a-f5ac2aea7842 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | 311759 242438 |
| Montelukast Sodium | MONTELUKAST | Amneal Pharmaceuticals LLC | bcd49102-a21c-4628-a322-6cdd934e7f09 | 2025-04-18 | Boxed warning, Warnings, Adverse reactions | 311759 242438 |
| RID Poison Ivy Rash Relief | CALAMINE AND ZINC OXIDE | Oystershell Consumer Health Inc. | 36c3af9a-2646-4427-e063-6394a90a2c5e | 2025-03-13 | Warnings | 1K09F3G675 |
| Addiclenz | ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 25036c26-1c21-4e5a-b4db-b8e177458341 | 2025-03-11 | Warnings | Z0H242BBR1 |
| YVTYVT MICRODERMABRASION FACIAL SCRUB | YVTYVT MICRODERMABRASION FACIAL SCRUB | Beijing JUNGE Technology Co., Ltd. | 2f30fc45-42e2-c766-e063-6394a90a8d68 | 2025-02-28 | Warnings | OP1R32D61U |
| Calamine | FERRIC OXIDE RED | Preferred Pharmaceuticals Inc. | 326f3d80-c1bf-4cf0-a662-58e02ed7ee67 | 2025-02-12 | Warnings, Adverse reactions | 1K09F3G675 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.