AMLODIPINE BESYLATE

Product NDC: 42582-314
11-digit product format: 425820314
Labeler code: 42582
Product ID: 42582-314_fbea5b50-8303-4614-8dcc-40b761ea17b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMLODIPINE BESYLATE
Dosage form: TABLET
Route: ORAL
Labeler: Bi-Coastal Pharma International LLC
Application: ANDA077516
Marketing category: ANDA
Marketing start: 2016-10-05
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: 2020-12-31
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	42582-314		I	Inactivated by FDA	2026-09-14
excluded package	package	42582-314	42582-314-09	I	Inactivated by FDA	2026-09-14
excluded package	package	42582-314	42582-314-18	I	Inactivated by FDA	2026-09-14

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 · 45 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	42582-314-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42582-314-18	`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	42582-314-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42582-314-18	`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	42582-314-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42582-314-18	`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	42582-314-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42582-314-18	`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	42582-314-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42582-314-18	`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	42582-314-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42582-314-18	`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	42582-314-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42582-314-18	`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	42582-314-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42582-314-18	`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	42582-314-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42582-314-18	`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	42582-314-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42582-314-18	`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	42582-314-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42582-314-18	`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	42582-314-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42582-314-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42582-314-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42582-314-18	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42582-314-09	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42582-314-18	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42582-314-09	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42582-314-18	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077516-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-11
A077516-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-11
A077516-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-11

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL		2007-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2007-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2007-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL		2007-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2007-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2007-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077516-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077516-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077516-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077516-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077516-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077516-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077516-001	AB	1	`8072bd15b7f6…`

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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42582-314-09	2023-01-30	C162847	48780-1	f386c64a-3ba5-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP AMLODIPINE BESYLATE TABLETS, USP for oral administration Initial U.S. Approval: 1992
42582-314-18	2023-01-30	C162847	48780-1	f386c64a-3ba5-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP AMLODIPINE BESYLATE TABLETS, USP for oral administration Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42582-314-09	AMLODIPINE BESYLATE5 mg	90 in 1 BOTTLE	TABLET	90		3
42582-314-18	AMLODIPINE BESYLATE5 mg	500 in 1 BOTTLE	TABLET	500		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42582-314-09	EA - Each	42582-314	50490a4d-c9ff-442a-86d2-8ff949261f9e	1	2018-05-09
42582-314-18	EA - Each	42582-314	f1b05355-5a49-4de2-877f-ff0aacfca0fe	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42582-314	AMLODIPINE BESYLATE 2.5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [BI‐COASTAL PHARMA INTERNATIONAL LLC]	3	Legacy NDC, 2 package rows	20190109_705d4471-b1bc-49a7-a871-9c03f886b69e.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	705d4471-b1bc-49a7-a871-9c03f886b69e	3
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	705d4471-b1bc-49a7-a871-9c03f886b69e	3
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	705d4471-b1bc-49a7-a871-9c03f886b69e	3
308135	amlodipine 10 MG Oral Tablet	SCD	705d4471-b1bc-49a7-a871-9c03f886b69e	3
308136	amlodipine 2.5 MG Oral Tablet	SCD	705d4471-b1bc-49a7-a871-9c03f886b69e	3
197361	amlodipine 5 MG Oral Tablet	SCD	705d4471-b1bc-49a7-a871-9c03f886b69e	3
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	705d4471-b1bc-49a7-a871-9c03f886b69e	3
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	705d4471-b1bc-49a7-a871-9c03f886b69e	3
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	705d4471-b1bc-49a7-a871-9c03f886b69e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42582-314-09	42582031409	90 TABLET in 1 BOTTLE (42582-314-09)	90 tablet	2016-10-05	0000-00-00	No	No	Current
42582-314-18	42582031418	500 TABLET in 1 BOTTLE (42582-314-18)	500 tablet	2016-10-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMLODIPINE BESYLATE 2.5 mg	Bi‐Coastal Pharma International LLC \| Strides Vivimed Pte. Ltd. \| Vivimed Life Sciences Private Limited	2019-01-09	HUMAN PRESCRIPTION DRUG LABEL	3