NDC 70518-3133-01 - Montelukast
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
- 70518-3133
- Requested NDC
- 70518-3133-01
- Package NDCs from labels
- 70518-3133-0, 70518-3133-1, 70518-3133-2, 70518-3133-01
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2026-04-03
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Montelukast - REMEDYREPACK INC. | REMEDYREPACK INC. | 2026-04-03 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-3133-0 | Montelukast | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | 9 | |
| 70518-3133-1 | Montelukast | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 9 | |
| 70518-3133-2 | Montelukast | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3133 | MONTELUKAST TABLET, FILM COATED [REMEDYREPACK INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240314_ecaa9b4b-5941-4af5-930c-35e9f3b2b4ba.zip |
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 |
|---|---|---|---|---|---|---|
| BareMinerals Mineral Veil | TITANIUM DIOXIDE AND ZINC OXIDE | Orveon Global US LLC | 64b163dd-8a86-483f-8dab-80fa8740b12f | 2023-10-04 | Warnings | 15FIX9V2JP |
| Montelukast Sodium | MONTELUKAST SODIUM | Proficient Rx LP | 07d5fbea-b183-41c9-a20f-30da1f44ab1b | 2023-10-01 | Warnings, Adverse reactions | U1O3J18SFL |
| DR ANDREW WEILS FOR ORIGINS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45 | TITANIUM DIOXIDE AND ZINC OXIDE | ORIGINS NATURAL RESOURCES INC. | 11248cab-c3a5-4e16-8280-9f70bb863cf7 | 2023-09-11 | Warnings | 15FIX9V2JP |
| AnubisMed | SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION | ANUBIS COSMETICS SL | e99d92c4-8768-9c0a-e053-2a95a90a609e | 2023-09-05 | Warnings | 15FIX9V2JP |
| 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 | 15FIX9V2JP |
| Anubis Barcelona Protective Line | ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE | ANUBIS COSMETICS SL | ec83846f-11c0-8f59-e053-2995a90ab9d2 | 2023-09-01 | Warnings | 15FIX9V2JP |
| Anubis Barcelona Spa Line | ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID | ANUBIS COSMETICS SL | eb01a962-ab38-18ec-e053-2995a90acdeb | 2023-09-01 | Warnings | 15FIX9V2JP |
| 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 | U1O3J18SFL |
| Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium Shade | SPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADE | Autumn Harp | fd6807e1-c8c0-b361-e053-6294a90aea0c | 2023-06-05 | Warnings | 15FIX9V2JP |
| Montelukast Sodium | MONTELUKAST SODIUM | Aurobindo Pharma Limited | 9a3bfc59-0ca6-4433-abf5-41659bfe0a8f | 2023-06-03 | Boxed warning, Warnings, Adverse reactions | U1O3J18SFL |
| Thinksport Mineral SPF 50 | ZINC OXIDE AND TITANIUM DIOXIDE | thinkOperations,LLC | 77b63c0b-353b-4f5f-95c7-6f7eeab81471 | 2023-05-30 | Warnings | 15FIX9V2JP |
| Think Kids Mineral SPF 50 | ZINC OXIDE AND TITANIUM DIOXIDE | thinkOperations,LLC | 25c59820-a08d-4abe-87ae-a787ac8b2ac2 | 2023-05-30 | Warnings | 15FIX9V2JP |
| Ferrum Oxydatum | FERRUM OXYDATUM | Hahnemann Laboratories, INC. | f8b52d3f-3fe2-a850-e053-6394a90a5d9f | 2023-04-06 | 1K09F3G675 | |
| Mannitol | MANNITOL | Fresenius Kabi USA, LLC | c395e13d-6ea1-4104-8b37-669cfb982f04 | 2023-03-16 | Warnings, Adverse reactions | 3OWL53L36A |
| Montelukast Sodium | MONTELUKAST SODIUM | Proficient Rx LP | 461f2aaa-e091-478e-97c1-27a089db8cdc | 2023-03-01 | Boxed warning, Warnings, Adverse reactions | 200224 U1O3J18SFL |
| Mineral Sunscreen SPF 50 | ZINC OXIDE TITANIUM DIOXIDE | Topiderm, Inc. | 3a637542-0f79-47ae-815d-84d0036c737a | 2023-02-13 | Warnings | 15FIX9V2JP |
| Montelukast | MONTELUKAST | Macleods Pharmaceuticals Limited | e0c5b856-3f70-4ca6-9763-a90673bb82fb | 2023-01-21 | Boxed warning, Warnings, Adverse reactions | 200224 U1O3J18SFL |
| Montelukast | MONTELUKAST | XLCare Pharmaceuticals Inc. | 82d65eea-c7c9-4e16-9176-46c43f00f0f6 | 2023-01-17 | Boxed warning, Warnings, Adverse reactions | ANDA202843 200224 U1O3J18SFL |
| Josie Maran Argan Daily Moisturizer SPF47 | ZINC OXIDE, TITANIUM DIOXIDE | Autumn Harp, Inc. | 027821e6-db7d-4c03-956a-00313488ebc7 | 2023-01-14 | Boxed warning, Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.