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 |
|---|---|---|---|---|---|---|
| Artificial Sweetener Detox 6034 | ARTIFICIAL SWEETENER DETOX | Professional Complementary Health Formulas | 38f2ae0b-2b1f-4b49-934d-fe1556f84d93 | 2026-01-08 | Warnings | Z0H242BBR1 |
| Thio Combination 9306 | THIO COMBINATION | Professional Complementary Health Formulas | 36e84795-bfb4-4483-9a2c-e14131ce1bea | 2026-01-08 | Warnings | Z0H242BBR1 |
| Third Chakra (Solar Plexus) 7303 | THIRD CHAKRA (SOLAR PLEXUS) | Professional Complementary Health Formulas | eea89c37-ab87-4cc7-8dfc-e7f42a580dd9 | 2026-01-08 | Warnings | 1K09F3G675 |
| Dermagesic | PRAMOXINE HCL, ZINC OXIDE, CALAMINE | Llorens Pharmaceutical International Division | bbff6b53-29da-45c1-8ccd-3e9df7f250e0 | 2025-12-31 | Warnings | 1K09F3G675 |
| BABY ANTI MONKEY BUTT DIAPER RASH | ZINC OXIDE, CALAMINE | Clarion Brands, LLC | e4424d74-f89c-5943-42e8-bf3a38e68619 | 2025-12-23 | Warnings | 1K09F3G675 |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Chartwell RX, LLC | 5cb4298c-10b1-4d6f-95ad-4aad72daf249 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 311759 242438 |
| Montelukast Sodium | MONTELUKAST SODIUM | AvKARE | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 2025-12-16 | Warnings, Adverse reactions | 311759 242438 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | Kroger Co. | 6b3e7aac-395f-48cf-9c5e-f7e163724aef | 2025-11-17 | Warnings | 1K09F3G675 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | HY-VEE, INC | 415ecfe9-3145-f23e-e063-6394a90adfd8 | 2025-11-17 | Warnings | 1K09F3G675 |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 8f8f53e3-fe31-e7b5-e053-2995a90a710d | 2025-11-14 | Warnings | 3OWL53L36A |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 9984a510-30be-4013-e053-2995a90a841e | 2025-11-14 | Warnings | 3OWL53L36A |
| Au Kah Chuen Fugical | CALAMINE AND DIPHENHYDRAMINE HYDROCHLORID | Zhejiang Dingtai Pharmaceutical Co., Ltd | 5b4add17-6c3d-4093-826a-2edb41c1d1db | 2025-11-10 | Warnings | 1K09F3G675 |
| FARGELIN HEMORRHOIDAL | CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE | MADISON ONE ACME INC | 6844ad63-512d-496a-9458-011894185b0d | 2025-11-10 | Warnings | 1K09F3G675 |
| Mannitol | MANNITOL | ProPharma Distribution | 430669d7-9ad1-9a04-e063-6394a90ababb | 2025-11-07 | Warnings, Adverse reactions | 3OWL53L36A |
| Calamine Plus | CALAMINE PLUS PRAMOXINE HCL | Chain Drug Marketing Association Inc | 1a3f8819-58cf-8923-e063-6394a90a37af | 2025-11-06 | Warnings | 1K09F3G675 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS NO TOUCH SPRAY | Premier Brands of America Inc. | 36481d67-2346-470b-e063-6294a90aae99 | 2025-11-03 | Warnings | 1K09F3G675 |
| Calamine Plus | CALAMINE PLUS PRAMOXINE HCL | AmerisourceBergen Drug Corporation | f161e151-4fab-2fbc-e053-2a95a90a5437 | 2025-10-30 | Warnings | 1K09F3G675 |
| REMEDY Calazime Skin Protectant | CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 1295cfcc-5b61-481b-964b-f53ffd0cb58e | 2025-10-30 | Warnings | 1K09F3G675 |
| Calamine Plus | CALAMINE PLUS PRAMOXINE HCL | Meijer Distribution Inc. | 03c46823-0b1f-4101-e063-6294a90aaf94 | 2025-10-30 | Warnings | 1K09F3G675 |
| Sorbitol-Mannitol | SORBITOL AND MANNITOL | ICU Medical Inc. | 5b44e248-4b7b-4777-954a-921c7b309944 | 2025-10-30 | Warnings, Adverse reactions | 3OWL53L36A |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.