NDC 13668-531-11 - 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
- 13668-531
- Requested NDC
- 13668-531-11
- Package NDCs from labels
- 13668-531-11, 13668-531-94, 13668-531-53
- Manufacturer
- Torrent Pharmaceuticals Limited | Torrent Pharma, Inc.
- Effective date
- 2026-07-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Montelukast Sodium - Torrent Pharmaceuticals Limited | Torrent Pharma, Inc. | Torrent Pharmaceuticals Limited | Torrent Pharma, Inc. | 2026-07-28 | HUMAN PRESCRIPTION DRUG LABEL |
| MONTELUKAST SODIUM ORAL - Torrent Pharmaceuticals Limited | Torrent Pharma, Inc. | Torrent Pharmaceuticals Limited | Torrent Pharma, Inc. | 2018-08-02 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13668-531-11 | Montelukast Sodium | 500 mg in 1 PACKET | GRANULE | 500 | 23 | |
| 13668-531-94 | Montelukast Sodium | 30 in 1 CARTON | GRANULE | 30 | 23 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 13668-531 | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM GRANULE [TORRENT PHARMACEUTICALS LIMITED] | 22 | Current NDC, Legacy NDC, 2 package rows | 20250529_da038cf6-cfad-43a4-ab8e-d81d028d6087.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13668-531-11 | EA - Each | 13668-531 | ac0dd939-f29a-4c21-9ff1-33afb145801d | 1 | 2018-11-06 |
| 13668-531-94 | EA - Each | 13668-531 | 6f90087b-509c-4bb2-9b3d-720a75be4eb7 | 1 | 2019-06-19 |
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 |
|---|---|---|---|---|---|---|
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | W Aesthetics | 5b0f2c8f-d6fa-5e25-e063-6394a90a084d | 2026-09-09 | Warnings | 15FIX9V2JP |
| 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 |
| MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50 | SUNSCREEN SPF50 | Guangzhou Meixi Biotechnology Co., Ltd. | 5a0b4bd2-f6ad-35dc-e063-6294a90a8a66 | 2026-08-27 | Warnings | 15FIX9V2JP |
| MELAO Hydrating Lightweight Sunscreen | AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE | Guangdong Aimu Biological Technology Co., Ltd | 59eeaea1-d726-99f3-e063-6394a90aeea3 | 2026-08-26 | Warnings | 15FIX9V2JP |
| Calamine Plus | CALAMINE, PRAMOXINE HYDROCHLORIDE | Kroger Company | 44fdd5a4-3cac-15e5-e063-6294a90adb52 | 2026-08-26 | Warnings | 1K09F3G675 |
| Q Skin Science | SUNSCREEN | International Cosmeceuticals, Inc | 59e4c3d0-ee4c-2350-e063-6394a90ac9d2 | 2026-08-25 | Warnings | 15FIX9V2JP |
| MELAO zinc stick(GREEN) | TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE | Guangzhou Haishi Biological Technology Co., Ltd. | 59c70c82-f7ff-9a04-e063-6294a90a7b3d | 2026-08-24 | Warnings | 15FIX9V2JP |
| SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01 | ZINC OXIDE, TITANIUM DIOXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 59d74e3f-e3fa-a7a9-e063-6294a90a76e5 | 2026-08-24 | Warnings | 15FIX9V2JP |
| Sweat Resistant Sunscreen Body Original | TITANIUM DIOXIDE, ZINC OXIDE | Clutch, Inc. | 4bbde755-e312-123e-e063-6294a90a467f | 2026-08-20 | Warnings | 15FIX9V2JP |
| HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN | ZINC OXIDE,TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 4339df13-77d3-31a1-e063-6394a90a5208 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | HAMBLIN DERMATOLOGY | 5942e64c-416e-7525-e063-6394a90a2839 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Protect Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | Opal Day Spa | 5943413a-48e1-0bdf-e063-6294a90a2fff | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | MedSpa By Beauty Bar LLC | 5943ba3d-688e-9e9c-e063-6294a90afa9a | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | CORBY, JR., TERRY L. | 594443fd-8e27-4ec6-e063-6294a90a3ff0 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | DR. SAMRAO'S OFFICE | 58b2ca35-11ed-d848-e063-6294a90a5b37 | 2026-08-11 | Warnings | 15FIX9V2JP |
| Journee Firm Riche Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE AND ZINC OXIDE | Merz North America, Inc. | d4d4bfcf-3674-4847-8ad8-1716a8e821ae | 2026-08-10 | Warnings | 15FIX9V2JP |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.