Amlodipine besylate

Product NDC: 13668-023
Requested package NDC: 13668-023-90
11-digit product format: 136680023
Labeler code: 13668
Product ID: 13668-023_ba0da07a-107e-2c66-e053-2995a90ab96a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA078573
Marketing category: ANDA
Marketing start: 2009-02-05
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE
Active strength: 5 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	13668-023	13668-023-90	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

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

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	Approval date
A078573-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22
A078573-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22
A078573-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078573-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2008-09-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078573-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2008-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078573-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2008-09-22	`8072bd15b7f6…`

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	A078573-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078573-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078573-003	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A078573-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078573-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078573-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078573-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078573-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078573-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078573-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078573-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078573-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078573-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078573-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078573-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078573-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078573-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078573-003	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-023-03	EA - Each	13668-023	d99bde97-6997-4cc7-985f-3d88084876ea	1	2012-07-24
13668-023-05	EA - Each	13668-023	c8f21a13-d9c5-4bfa-9d54-d937a1cce06b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	8
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	8
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	AMLODIPINE BESYLATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMLODIPINE BESYLATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	8

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-023-90	13668002390	90 TABLET in 1 BOTTLE (13668-023-90)	90 tablet	2009-02-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine besylate	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2021-01-29	HUMAN PRESCRIPTION DRUG LABEL	10