NDC 68788-8665-09 - Telmisartan
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
- 68788-8665
- Requested NDC
- 68788-8665-09
- Package NDCs from labels
- 68788-8665-3, 68788-8665-6, 68788-8665-9, 68788-8665-09
- Manufacturer
- Preferred Pharmaceuticals Inc.
- Effective date
- 2026-09-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Telmisartan - Preferred Pharmaceuticals Inc. | Preferred Pharmaceuticals Inc. | 2026-09-28 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-8665-3 | Telmisartan | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 68788-8665-6 | Telmisartan | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 68788-8665-9 | Telmisartan | 90 in 1 BOTTLE | TABLET | 90 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8665 | TELMISARTAN TABLET [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 3 package rows | 20240531_d45da80a-58c3-4461-adf6-a85531c09eb8.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8665-3 | EA - Each | 68788-8665 | 5150b063-8347-4b10-8282-50ae1239b316 | 1 | 2024-07-12 |
| 68788-8665-6 | EA - Each | 68788-8665 | c48d295f-11b8-4e5f-94af-25fcb0b7b834 | 1 | 2024-07-12 |
| 68788-8665-9 | EA - Each | 68788-8665 | 106ce74e-2b4f-4fb8-a360-c6ecf6a3e470 | 1 | 2024-07-12 |
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 |
|---|---|---|---|---|---|---|
| Telmisartan and Hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | AvKARE | 1b303136-dccd-178b-e063-6394a90a35f8 | 2026-09-08 | Boxed warning, Warnings, Adverse reactions | U5SYW473RQ |
| Telmisartan | TELMISARTAN | REMEDYREPACK INC. | 57da6ef2-2e86-4e4d-90df-73a2a8cf97f6 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | ANDA207882 205305 U5SYW473RQ |
| Telmisartan | TELMISARTAN | REMEDYREPACK INC. | 91215664-6e19-4e04-9ae7-ab5664799426 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 205305 U5SYW473RQ |
| Telmisartan | TELMISARTAN | Redpharm Drug | 5743c58e-deab-ac93-e063-6294a90ac1eb | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | 282755 U5SYW473RQ |
| WIDAPLIK | TELMISARTAN, AMLODIPINE AND INDAPAMIDE | Azurity Pharmaceuticals, Inc. | a30ff81d-420b-40ea-83d8-670260a93fff | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | U5SYW473RQ |
| telmisartan | TELMISARTAN | REMEDYREPACK INC. | 09d31eee-cd22-4918-a889-3eb4d2969525 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 205305 U5SYW473RQ |
| Telmisartan | TELMISARTAN | Alembic Pharmaceuticals Limited | 4be6575f-ea8d-4cd8-a49d-3d1c93f2621a | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 205304 282755 205305 U5SYW473RQ |
| Telmisartan | TELMISARTAN | Alembic Pharmaceuticals Inc. | c62d424c-7630-413c-be2c-3932831c3f1d | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 205304 282755 205305 U5SYW473RQ |
| Telmisartan | TELMISARTAN | Bryant Ranch Prepack | 830741dd-3f3c-4f8e-88c6-dc112166f477 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | ANDA207882 205305 U5SYW473RQ |
| Telmisartan | TELMISARTAN | Bryant Ranch Prepack | a5ded796-3555-4476-8b37-0cdc88d7594a | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | ANDA207882 205304 U5SYW473RQ |
| Telmisartan | TELMISARTAN | Bryant Ranch Prepack | c55e4fe1-f04d-4995-a706-9f432fde57e4 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 205305 U5SYW473RQ |
| Mannitol | MANNITOL | Hospira, Inc. | 8ad3145e-00e7-4412-b9a5-06f00f264f30 | 2026-04-21 | Warnings, Adverse reactions | 3OWL53L36A |
| Telmisartan | TELMISARTAN | Glenmark Pharmaceuticals Inc., USA | c6eb489d-2946-4c14-839f-d4af761ead31 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 205304 282755 205305 U5SYW473RQ |
| Telmisartan | TELMISARTAN | Macleods Pharmaceuticals Limited | 671d5a85-4146-43b4-9d7d-ca53268eb2a6 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 205304 282755 205305 U5SYW473RQ |
| Telmisartan | TELMISARTAN | AvKARE | 71902893-55da-4286-8b25-b528641489ef | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 205304 282755 205305 U5SYW473RQ |
| Telmisartan | TELMISARTAN | Solco Healthcare US, LLC | 77442f0b-b522-4b19-ac1f-f0ce8576f0be | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | ANDA207882 43547-284 205304 282755 205305 98f95e17-f88b-4f47-b4bb-5db8f93793f7 77442f0b-b522-4b19-ac1f-f0ce8576f0be U5SYW473RQ |
| Telmisartan and Hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Lupin Pharmaceuticals, Inc. | b88054b3-fafa-4b4e-acf5-5294e5555720 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | U5SYW473RQ |
| Telmisartan and Hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Glenmark Pharmaceuticals Inc., USA | 1e55800d-f77c-4950-a6d7-2055f4c7ea17 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | U5SYW473RQ |
| Telmisartan | TELMISARTAN | A-S Medication Solutions | eaed12cd-5bfe-4c98-9afc-025ed86a294f | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | 205304 U5SYW473RQ |
| TELMISARTAN | TELMISARTAN | Chartwell RX, LLC. | beaaf383-730f-4411-b5e7-15c32b53a338 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | 205304 282755 205305 U5SYW473RQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.