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 |
|---|---|---|---|---|---|---|
| Prunus Iron | PRUNUS IRON | Uriel Pharmacy Inc. | 091be588-b62e-4919-8e9e-3edb9792d319 | 2025-01-22 | Warnings | 1K09F3G675 |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | DIRECT RX | c2d834e6-7b38-d266-e053-2995a90a27ef | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | ANDA204093 242438 MHM278SD3E |
| A-15 | APPLE, APRICOT, BANANA, CHERRY, GRAPE, PEACH, PINEAPPLE, PEAR, AND STRAWBERRY | DNA Labs, Inc. | 142841cc-8eee-4ed7-b0d3-70f081466628 | 2025-01-09 | Warnings | BUC5I9595W |
| Ferrum Silicicum Urtica | FERRUM SILICICUM URTICA | Uriel Pharmacy Inc. | 09829ac4-c074-7315-e063-6394a90adf59 | 2025-01-07 | Warnings | 1K09F3G675 |
| Addiclenz | 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, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Deseret Biologicals, Inc. | 8a3b75ca-8fec-4318-8a55-8bde0b82637d | 2024-10-31 | Warnings | Z0H242BBR1 |
| Caladryl | FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE | Bausch Health US, LLC | 67d4fd42-9fed-4238-9f5a-c9403abbcf20 | 2024-10-17 | Warnings | 1K09F3G675 |
| montelukast sodium | MONTELUKAST SODIUM | Bryant Ranch Prepack | 3ff4100f-11e3-4d6a-ab88-83bd605a1818 | 2024-10-07 | Boxed warning, Warnings, Adverse reactions | ANDA204093 311759 |
| Spectric | AGARICUS MUSCARIUS, ASPARTAME, BUFO RANA, CARCINOSIN, CEREBRUM SUIS, ETHYLICUM, HELLEBORUS NIGER, HYDROGEN, HYOSCYAMUS NIGER, KALI BROMATUM, L-DOPA, NEON, OLIBANUM (BOSWELLIA SERRATA), PLACENTA TOTALIS SUIS, SEROTONIN (HYDROCHLORIDE), STRAMONIUM, THUJA OCCIDENTALIS | Deseret Biologicals, Inc | 4ee7f979-c30d-4062-a453-27b6b0b38247 | 2024-09-23 | Warnings | Z0H242BBR1 |
| Calamine | CALAMINE AND ZINC OXIDE | Strategic Sourcing Services, LLC | 22173332-9d09-768c-e063-6394a90a94e1 | 2024-09-14 | Warnings | 1K09F3G675 |
| Spectric | ETHYLICUM, KALI BROMATUM, ASPARTAME, L-DOPA, SEROTONIN (HYDROCHLORIDE), CEREBRUM SUIS, PLACENTA TOTALIS SUIS, AGARICUS MUSCARIUS, BUFO RANA, HELLEBORUS NIGER, HYOSCYAMUS NIGER, OLIBANUM (BOSWELLIA SERRATA), STRAMONIUM, THUJA OCCIDENTALIS, HELIUM, NEON, CARCINOSIN, HYDROGEN | Deseret Biologicals, Inc | d1981aca-de84-404d-8d38-3a013a531426 | 2024-09-11 | Warnings | Z0H242BBR1 |
| Multi-Phenolic | MANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN, | Energique, Inc. | 492b412a-01cc-48f2-bcdc-6fffcc651963 | 2024-08-23 | Warnings | Z0H242BBR1 |
| Calamine | FERRIC OXIDE RED | NuCare Pharmaceuticals,Inc. | 66e98554-e158-a519-e053-2a91aa0a6783 | 2024-06-06 | Warnings, Adverse reactions | 1K09F3G675 |
| Montelukast Sodium | MONTELUKAST SODIUM | Aurobindo Pharma Limited | ba42b0a9-83f1-4283-a853-f99cdd0761b9 | 2024-03-30 | Boxed warning, Warnings, Adverse reactions | 311759 242438 |
| MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | 999ce711-2d5b-0d7d-e053-2995a90a2689 | 2024-01-27 | Warnings, Adverse reactions | 3OWL53L36A |
| Montelukast Sodium | MONTELUKAST SODIUM | Proficient Rx LP | 07d5fbea-b183-41c9-a20f-30da1f44ab1b | 2023-10-01 | Warnings, Adverse reactions | 311759 |
| Lipotox | SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, | BioActive Nutritional, Inc. | a1538692-ca00-4e52-9b7e-409767ee27e1 | 2023-09-05 | Warnings | Z0H242BBR1 |
| Mannitol | MANNITOL | B. Braun Medical Inc. | d12cc802-b538-4065-a264-f474ff3b3043 | 2023-08-15 | Warnings, Adverse reactions | 3OWL53L36A |
| Montelukast Sodium | MONTELUKAST SODIUM | Lannett Company, Inc. | c43d1edb-c162-4317-9a89-d84e4eff5512 | 2023-07-11 | Boxed warning, Warnings, Adverse reactions | 311759 242438 |
| Montelukast sodium | MONTELUKAST SODIUM | Macleods Pharmaceuticals Limited | ce512844-5220-4661-809f-56d088699c9c | 2023-07-06 | Boxed warning, Warnings, Adverse reactions | 311759 242438 MHM278SD3E |
| Ferrum Oxydatum | FERRUM OXYDATUM | Hahnemann Laboratories, INC. | f8b52d3f-3fe2-a850-e053-6394a90a5d9f | 2023-04-06 | 1K09F3G675 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.