WIDAPLIK
- Product NDC
- 24338-003
- 11-digit product format
- 243380003
- Labeler code
- 24338
- Product ID
- 24338-003_d5293244-59c5-44b0-b82b-0f1cf863d8fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- telmisartan, amlodipine and indapamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Azurity Pharmaceuticals, Inc.
- Application
- NDA219423
- Marketing category
- NDA
- Marketing start
- 2025-10-20
- Substance
- AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
- Active strength
- 5; 2.5; 40 mg/1; mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- WIDAPLIK
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| INDAPAMIDE | 2.5 mg/1 |
| TELMISARTAN | 40 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | U5SYW473RQ, 864V2Q084H, F089I0511L |
| Rxcui | 2727452, 2727458, 2727460, 2727462, 2727463, 2727465 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa898d56-9495-d6f0-309b-68a5d8e3914a | Product name | 4 | 20260305 |
| c19ec24d-2c40-4b8d-7c20-500ffa3660a1 | Product name | 3 | 20260303 |
| b15e9aa6-d523-ca97-480e-570e0543a342 | Product name | 4 | 20251024 |
| 265792b3-b999-c010-7364-a7db20b9d4d9 | Product name | 5 | 20250515 |
| 14c2c15b-f823-4ada-a40e-a440544294dc | Product name | 1 | 20221207 |
| a72887ef-d675-499f-af4b-78688f6855cd | Product name | 1 | 20191002 |
| 8b67f333-47d1-8464-7ce4-406d3dbb295f | Product name | 7 | 20190618 |
| a4484670-2869-6416-f6ff-03b1b3cbd1b0 | Product name | 2 | 20190415 |
| 4a27501f-a987-48a5-99b4-e983d4744d76 | Product name | 7 | 20181211 |
| 18600d07-613d-bf9c-2711-fe40c06f3393 | Product name | 5 | 20180703 |
| 796916df-49fa-d043-64a7-fee11194676c | Product name | 9 | 20171130 |
| bded1554-44de-900a-5297-403365d6d4b2 | Product name | 3 | 20170110 |
| 1f1c6e4b-bbad-4649-afd1-7a1d671db4b1 | Product name | 1 | 20150316 |
| 2bda0d04-c82b-7786-6ed9-2a416b849e7a | Product name | 1 | 20140508 |
| 63ab5fbf-2a6b-c41d-051a-39e845d718b1 | Product name | 1 | 20140508 |
| 7613b1a5-acb6-4e5e-6048-c44deeeb1212 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24338-003-30 | WIDAPLIK | 30 in 1 BOTTLE | TABLET | 30 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24338-003-30 | EA - Each | 24338-003 | 8f90d701-b941-4ebe-a7b0-4704a0debf63 | 1 | 2026-05-22 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2727452 | telmisartan 10 MG / amLODIPine 1.25 MG / indapamide 0.625 MG Oral Tablet | PSN | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727460 | telmisartan 20 MG / amLODIPine 2.5 MG / indapamide 1.25 MG Oral Tablet | PSN | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727463 | telmisartan 40 MG / amLODIPine 5 MG / indapamide 2.5 MG Oral Tablet | PSN | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727458 | Widaplik 10 MG / 1.25 MG / 0.625 MG Oral Tablet | PSN | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727462 | Widaplik 20 MG / 2.5 MG / 1.25 MG Oral Tablet | PSN | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727465 | Widaplik 40 MG / 5 MG / 2.5 MG Oral Tablet | PSN | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727458 | amlodipine 1.25 MG / indapamide 0.625 MG / telmisartan 10 MG Oral Tablet [Widaplik] | SBD | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727462 | amlodipine 2.5 MG / indapamide 1.25 MG / telmisartan 20 MG Oral Tablet [Widaplik] | SBD | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727465 | amlodipine 5 MG / indapamide 2.5 MG / telmisartan 40 MG Oral Tablet [Widaplik] | SBD | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727452 | amlodipine 1.25 MG / indapamide 0.625 MG / telmisartan 10 MG Oral Tablet | SCD | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727460 | amlodipine 2.5 MG / indapamide 1.25 MG / telmisartan 20 MG Oral Tablet | SCD | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727463 | amlodipine 5 MG / indapamide 2.5 MG / telmisartan 40 MG Oral Tablet | SCD | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727452 | amlodipine (as amlodipine besylate) 1.25 MG / indapamide 0.625 MG / telmisartan 10 MG Oral Tablet | SY | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727460 | amlodipine (as amlodipine besylate) 2.5 MG / indapamide 1.25 MG / telmisartan 20 MG Oral Tablet | SY | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727463 | amlodipine (as amlodipine besylate) 5 MG / indapamide 2.5 MG / telmisartan 40 MG Oral Tablet | SY | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727458 | Widaplik 10 MG / 1.25 MG / 0.625 MG Oral Tablet | SY | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727462 | Widaplik 20 MG / 2.5 MG / 1.25 MG Oral Tablet | SY | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
| 2727465 | Widaplik 40 MG / 5 MG / 2.5 MG Oral Tablet | SY | a30ff81d-420b-40ea-83d8-670260a93fff | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 24338-003-30 | 24338000330 | 30 TABLET in 1 BOTTLE (24338-003-30) | 30 tablet | 2025-10-20 | No | No | Historical |