Telmisartan and Amlodipine

Product NDC: 13668-345
11-digit product format: 136680345
Labeler code: 13668
Product ID: 13668-345_dafb950c-aa32-fe74-e053-2a95a90a9016
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Telmisartan and Amlodipine
Dosage form: TABLET
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA202517
Marketing category: ANDA
Marketing start: 2014-01-08
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE; TELMISARTAN
Active strength: 10 mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13668-345		D	Discontinued by firm	2026-10-05
excluded package	package	13668-345	13668-345-01	D	Discontinued by firm	2026-10-05
excluded package	package	13668-345	13668-345-30	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-345-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-345-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-345-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-345-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-345-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-345-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-345-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-345-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-345-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-345-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-345-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-345-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-345-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-345-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-345-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-345-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-345-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-345-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-345-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-345-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-345-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-345-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13668-345-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13668-345-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A202517-001	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08
A202517-002	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08
A202517-003	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08
A202517-004	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08

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	A202517-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202517-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202517-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202517-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202517-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202517-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202517-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202517-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202517-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202517-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202517-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202517-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202517-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202517-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202517-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202517-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202517-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202517-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202517-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202517-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202517-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202517-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202517-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202517-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202517-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202517-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202517-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202517-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202517-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202517-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202517-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202517-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202517-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202517-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202517-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202517-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202517-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202517-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202517-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202517-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A202517-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202517-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202517-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202517-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202517-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202517-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202517-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202517-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202517-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202517-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202517-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202517-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202517-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202517-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202517-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202517-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202517-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202517-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202517-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202517-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202517-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202517-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202517-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202517-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202517-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202517-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202517-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202517-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202517-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202517-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202517-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202517-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202517-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202517-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202517-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202517-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202517-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202517-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202517-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202517-004	AB	1	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-345-30	EA - Each	13668-345	b3cf6dc0-c867-4a83-8854-fa68b494a521	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3
TELMISARTAN	ACTIVE INGREDIENT	U5SYW473RQ	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3
AMLODIPINE	ACTIVE MOIETY	1J444QC288	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3
TELMISARTAN	ACTIVE MOIETY	U5SYW473RQ	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	TELMISARTAN AND AMLODIPINE TABLET [TORRENT PHARMACEUTICALS LIMITED]	3

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-345-01	13668034501	100 TABLET in 1 BOTTLE (13668-345-01)	100 tablet	2014-01-08	0000-00-00	No	No	Current
13668-345-30	13668034530	30 TABLET in 1 BOTTLE (13668-345-30)	30 tablet	2014-01-08	0000-00-00	No	No	Current
13668-345-74	13668034574	100 TABLET in 1 CARTON (13668-345-74)	100 tablet	2014-01-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Telmisartan and Amlodipine	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2022-03-24	HUMAN PRESCRIPTION DRUG LABEL	8