NDC 0781-5560-06 - 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
- 0781-5560
- Requested NDC
- 0781-5560-06
- Package NDCs from labels
- 0781-5560-31, 0781-5560-92, 0781-5560-06, 0781-5560-13
- Manufacturer
- Sandoz Inc
- Effective date
- 2025-06-13
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Montelukast - Sandoz Inc | Sandoz Inc | 2025-06-13 | HUMAN PRESCRIPTION DRUG LABEL |
| Montelukast - Bryant Ranch Prepack | Bryant Ranch Prepack | 2022-02-08 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0781-5560-06 | Montelukast | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 15 | |
| 0781-5560-13 | Montelukast | 10 in 1 CARTON | TABLET, FILM COATED | 10 | 15 | |
| 0781-5560-31 | Montelukast | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 15 | |
| 0781-5560-92 | Montelukast | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-5560-31 | EA - Each | 0781-5560 | 76e59a27-0faa-42dd-b2e1-eaa047f27cac | 1 | 2013-02-13 |
| 0781-5560-92 | EA - Each | 0781-5560 | 1c260048-a465-4f77-a3b1-d38b9d50dcc1 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| VEIRFOO Brightening Hydrating Antiwrinkle Sunscreen | TITANIUM DIOXIDE, OCTINOXATE | LCM TECHNOLOGY Co., Ltd | 4cbbf8aa-8910-b7e7-e063-6294a90a4f07 | 2026-08-07 | Warnings | 15FIX9V2JP |
| Calamine | FERRIC OXIDE RED | The Kroger Co. | 9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308 | 2026-08-06 | Warnings, Adverse reactions | 1K09F3G675 |
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 37fee381-ce6b-4949-9a4a-778aa839fb84 | 2026-08-06 | Warnings | 15FIX9V2JP |
| Montelukast | MONTELUKAST | Coupler LLC | 583a9499-97f0-2ebf-e063-6394a90a35af | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 200224 U1O3J18SFL |
| Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY | OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8% | Lale Cosmetics LLC | 581fb0cd-c55d-d562-e063-6394a90a7f11 | 2026-08-03 | Warnings | 15FIX9V2JP |
| EltaMD UV Active | ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN | CP Skin Health Group, Inc | 39d16479-d491-4c19-aa11-674461687c7b | 2026-08-03 | Warnings | 15FIX9V2JP |
| Continuous Correction Cream | TITANIUM DIOXIDE | Baxter of California, LLC | 1cbcc648-f2e1-af60-e063-6294a90ad4bb | 2026-07-31 | Warnings | 15FIX9V2JP |
| Cover Creme | TITANIUM DIOXIDE | Baxter of California | 31f5e8c4-523f-4596-e063-6294a90a6a12 | 2026-07-31 | Warnings | 15FIX9V2JP |
| Montelukast Sodium | MONTELUKAST SODIUM | Torrent Pharmaceuticals Limited | da038cf6-cfad-43a4-ab8e-d81d028d6087 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 200224 U1O3J18SFL |
| montelukast sodium | MONTELUKAST SODIUM | Preferred Pharmaceuticals Inc. | 1eeb3123-9e93-4681-8096-800a7c7acf8a | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 200224 U1O3J18SFL |
| Montelukast | MONTELUKAST | Preferred Pharmaceuticals, Inc. | 94642db1-5c75-44c4-92b4-8385b486df82 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 200224 U1O3J18SFL |
| Montelukast Sodium | MONTELUKAST SODIUM | Preferred Pharmaceuticals Inc. | 64a3b181-e8d8-4caf-9f1b-e0063d0bd94a | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 200224 U1O3J18SFL |
| ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | BEL STAR S.A. | 575fb2c3-e332-8a3b-e063-6394a90a9fd9 | 2026-07-24 | Warnings | 15FIX9V2JP |
| 601ac767-87c2-4aaf-aa84-408a3354b186 | e67c211a-cee7-41e8-9a2a-32d7363ef2a3 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | e67c211a-cee7-41e8-9a2a-32d7363ef2a3 | ||
| True Coast SPF 50 Mineral Sunscreen | ZINC OXIDE 18%, TITANIUM DIOXIDE 6% | Foshan Sugar Max Cosmetics CO.,Ltd | 5379466d-8d14-5fc2-e063-6394a90abd7e | 2026-07-22 | Warnings | 15FIX9V2JP |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 57110309-9a3d-025f-e063-6394a90a015a | 2026-07-22 | Warnings | 1K09F3G675 |
| Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation | OCTINOXATE AND TITANIUM DIOXIDE | SICOS ET CIE | 571f23e9-1126-e32d-e063-6294a90a9951 | 2026-07-21 | Warnings | 15FIX9V2JP |
| MENS SPF50 ALL IN ONE SUNSCREEN | MENS SPF50 ALL IN ONE SUNSCREEN | Lance (Guangzhou) Biological Technology Co., Ltd. | 57074480-77fd-cc06-e063-6294a90a28d4 | 2026-07-20 | Warnings | 15FIX9V2JP |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 571083ce-cd35-a638-e063-6394a90ae4c7 | 2026-07-20 | Warnings | 1K09F3G675 |
| Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation | OCTINOXATE AND TITANIUM DIOXIDE | L'Oreal USA Products Inc | 5711364c-f9b4-bfa6-e063-6294a90ace4a | 2026-07-20 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.