Telmisartan and Amlodipine

Product NDC: 46708-184
Requested package NDC: 46708-184-08
11-digit product format: 467080184
Labeler code: 46708
Product ID: 46708-184_f0d9160e-9405-435e-9f36-75c537267221
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Telmisartan and Amlodipine
Dosage form: TABLET
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA205234
Marketing category: ANDA
Marketing start: 2016-11-22
Substance: TELMISARTAN; AMLODIPINE BESYLATE
Active strength: 40; 5 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]
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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A205234-001	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17
A205234-002	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17
A205234-003	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17
A205234-004	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17

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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205234-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205234-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205234-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205234-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2016-11-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A205234-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205234-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205234-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205234-004	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A205234-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205234-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205234-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205234-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205234-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205234-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205234-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205234-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205234-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205234-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205234-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205234-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205234-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205234-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205234-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205234-004	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Telmisartan and Amlodipine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TELMISARTAN	40 mg/1
AMLODIPINE BESYLATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
876514	Internal RxNorm lookup
876519	Internal RxNorm lookup
876524	Internal RxNorm lookup
876529	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
15b438b4-4874-43f4-a50a-4e6f3e5530ac	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
46708-184-08	2023-02-01	C162847	48780-1	f386c649-f4fb-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TELMISARTAN AND AMLODIPINE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND AMLODIPINE TABLETS. TELMISARTAN and AMLODIPINE tablets, for oral use Initial U.S. Approval: 2009
46708-184-08	2023-01-30	C162847	48780-1	f386c649-f4fb-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TELMISARTAN AND AMLODIPINE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND AMLODIPINE TABLETS. TELMISARTAN and AMLODIPINE tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46708-184-08	Telmisartan and Amlodipine	8 in 1 BLISTER PACK	TABLET	8		4
46708-184-08	Telmisartan and Amlodipine	80 in 1 CARTON	TABLET	80		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-184	TELMISARTAN AND AMLODIPINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	4	Current NDC, Legacy NDC, 2 package rows	20230202_15b438b4-4874-43f4-a50a-4e6f3e5530ac.zip

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
Telmisartan and Amlodipine	TELMISARTAN AND AMLODIPINE	Alembic Pharmaceuticals Limited	15b438b4-4874-43f4-a50a-4e6f3e5530ac	2023-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205234 application number: ANDA205234 ndc (package): 46708-184-08 ndc (product): 46708-184 ndc11 (package): 46708018408

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
876514	telmisartan 40 MG / amLODIPine 10 MG Oral Tablet	PSN	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4
876524	telmisartan 40 MG / amLODIPine 5 MG Oral Tablet	PSN	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4
876519	telmisartan 80 MG / amLODIPine 10 MG Oral Tablet	PSN	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4
876529	telmisartan 80 MG / amLODIPine 5 MG Oral Tablet	PSN	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4
876514	amlodipine 10 MG / telmisartan 40 MG Oral Tablet	SCD	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4
876519	amlodipine 10 MG / telmisartan 80 MG Oral Tablet	SCD	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4
876524	amlodipine 5 MG / telmisartan 40 MG Oral Tablet	SCD	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4
876529	amlodipine 5 MG / telmisartan 80 MG Oral Tablet	SCD	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4
876514	amlodipine (as amlodipine besylate) 10 MG / telmisartan 40 MG Oral Tablet	SY	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4
876519	amlodipine (as amlodipine besylate) 10 MG / telmisartan 80 MG Oral Tablet	SY	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4
876524	amlodipine (as amlodipine besylate) 5 MG / telmisartan 40 MG Oral Tablet	SY	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4
876529	amlodipine (as amlodipine besylate) 5 MG / telmisartan 80 MG Oral Tablet	SY	15b438b4-4874-43f4-a50a-4e6f3e5530ac	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-184-08	46708018408	80 BLISTER PACK in 1 CARTON (46708-184-08) / 8 TABLET in 1 BLISTER PACK	80 blister pack	2016-11-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Telmisartan and Amlodipine	Alembic Pharmaceuticals Limited	2023-01-30	Human Prescription Drug Label	4