WIDAPLIK

Product NDC: 24338-002
Requested package NDC: 24338-002-30
11-digit product format: 243380002
Labeler code: 24338
Product ID: 24338-002_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: 2.5; 1.25; 20 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N219423-001	WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	EQ 1.25MG BASE;0.625MG;10MG	TABLET / ORAL	RLD	2025-06-05
N219423-002	WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	EQ 2.5MG BASE;1.25MG;20MG	TABLET / ORAL	RLD	2025-06-05
N219423-003	WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	EQ 5MG BASE;2.5MG;40MG	TABLET / ORAL	RLD	2025-06-05

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219423-001	10322117	2038-01-23		Drug product	2025-07-03
N219423-001	12465599	2038-01-23		Drug product	2025-11-18
N219423-002	10799487	2038-01-23	U-3448	Drug product	2025-07-03
N219423-002	12465599	2038-01-23		Drug product	2025-11-18
N219423-003	12673047	2038-01-23		Drug product	2026-07-09

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219423-001	NP	2028-06-05
N219423-002	NP	2028-06-05
N219423-003	NP	2028-06-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219423-001	WIDAPLIK	EQ 1.25MG BASE;0.625MG;10MG	TABLET / ORAL	RLD	2025-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-002	WIDAPLIK	EQ 2.5MG BASE;1.25MG;20MG	TABLET / ORAL	RLD	2025-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-003	WIDAPLIK	EQ 5MG BASE;2.5MG;40MG	TABLET / ORAL	RLD	2025-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-001	WIDAPLIK	EQ 1.25MG BASE;0.625MG;10MG	TABLET / ORAL	RLD	2025-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-002	WIDAPLIK	EQ 2.5MG BASE;1.25MG;20MG	TABLET / ORAL	RLD	2025-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-003	WIDAPLIK	EQ 5MG BASE;2.5MG;40MG	TABLET / ORAL	RLD	2025-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219423-001	WIDAPLIK	EQ 1.25MG BASE;0.625MG;10MG	TABLET / ORAL	RLD	2025-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-002	WIDAPLIK	EQ 2.5MG BASE;1.25MG;20MG	TABLET / ORAL	RLD	2025-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-003	WIDAPLIK	EQ 5MG BASE;2.5MG;40MG	TABLET / ORAL	RLD	2025-06-05	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-001	WIDAPLIK	EQ 1.25MG BASE;0.625MG;10MG	TABLET / ORAL	RLD	2025-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-002	WIDAPLIK	EQ 2.5MG BASE;1.25MG;20MG	TABLET / ORAL	RLD	2025-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-003	WIDAPLIK	EQ 5MG BASE;2.5MG;40MG	TABLET / ORAL	RLD	2025-06-05	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219423-001	10322117	2038-01-23		Drug product	2025-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-001	12465599	2038-01-23		Drug product	2025-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-002	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-002	12465599	2038-01-23		Drug product	2025-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-001	10322117	2038-01-23		Drug product	2025-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-001	12465599	2038-01-23		Drug product	2025-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-002	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-002	12465599	2038-01-23		Drug product	2025-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219423-001	10322117	2038-01-23		Drug product	2025-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-001	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-002	10322117	2038-01-23		Drug product	2025-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-002	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-003	10322117	2038-01-23		Drug product	2025-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-003	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-001	10322117	2038-01-23		Drug product	2025-07-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-001	12465599	2038-01-23		Drug product	2025-11-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-002	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-002	12465599	2038-01-23		Drug product	2025-11-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-003	12673047	2038-01-23		Drug product	2026-07-09	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219423-001	NP	2028-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-002	NP	2028-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-003	NP	2028-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-001	NP	2028-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-002	NP	2028-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-003	NP	2028-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219423-001	NP	2028-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-002	NP	2028-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-003	NP	2028-06-05	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-001	NP	2028-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-002	NP	2028-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-003	NP	2028-06-05	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: WIDAPLIK
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TELMISARTAN	2.5 mg/1
AMLODIPINE BESYLATE	1.25 mg/1
INDAPAMIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U5SYW473RQ	Internal UNII lookup
F089I0511L	Internal UNII lookup
864V2Q084H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2727452	Internal RxNorm lookup
2727458	Internal RxNorm lookup
2727460	Internal RxNorm lookup
2727462	Internal RxNorm lookup
2727463	Internal RxNorm lookup
2727465	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a30ff81d-420b-40ea-83d8-670260a93fff	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24338-002-30	WIDAPLIK	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24338-002-30	EA - Each	24338-002	56621d98-d9f8-4dac-9606-bfe7e15f27dd	1	2026-05-22

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WIDAPLIK	TELMISARTAN, AMLODIPINE AND INDAPAMIDE	Azurity Pharmaceuticals, Inc.	a30ff81d-420b-40ea-83d8-670260a93fff	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 219423 application number: NDA219423 ndc (package): 24338-002-30 ndc (product): 24338-002 ndc11 (package): 24338000230

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
F089I0511L	INDAPAMIDE	26807-65-8	INDAPAMIDE
U5SYW473RQ	TELMISARTAN	144701-48-4	TELMISARTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
24338-002-30	24338000230	30 TABLET in 1 BOTTLE (24338-002-30)	30 tablet	2025-10-20	No	No	Current