Amlodipine Besylate

Product NDC: 53002-3249
11-digit product format: 530023249
Labeler code: 53002
Product ID: 53002-3249_8259a611-cc96-44db-a66e-07e7bb48ba12
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA203245
Marketing category: ANDA
Marketing start: 2014-03-03
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: 2021-12-31
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	53002-3249		I	Inactivated by FDA	2026-08-11
excluded package	package	53002-3249	53002-3249-0	I	Inactivated by FDA	2026-08-11
excluded package	package	53002-3249	53002-3249-3	I	Inactivated by FDA	2026-08-11

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	53002-3249-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3249-0	`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	53002-3249-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3249-0	`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	53002-3249-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3249-0	`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	53002-3249-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3249-0	`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	53002-3249-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3249-0	`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	53002-3249-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3249-0	`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	53002-3249-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3249-0	`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	53002-3249-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3249-0	`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	53002-3249-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3249-0	`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	53002-3249-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53002-3249-0	`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	53002-3249-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53002-3249-0	`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	53002-3249-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53002-3249-0	`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	53002-3249-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53002-3249-0	`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	53002-3249-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53002-3249-0	`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	53002-3249-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53002-3249-0	`1332a3947898…`	`d4bfe170f9cd…`

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	TE codes	Approval date
A203245-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21
A203245-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21
A203245-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203245-001	AB
A203245-002	AB
A203245-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A203245-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203245-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203245-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203245-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203245-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203245-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203245-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203245-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203245-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203245-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203245-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203245-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203245-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203245-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203245-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203245-001	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
53002-3249-0	2023-01-30	C162847	48780-1	f386c649-d6d3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets for oral administration Initial U.S. Approval: 1992
53002-3249-3	2023-01-30	C162847	48780-1	f386c649-d6d3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets 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
53002-3249-0	Amlodipine Besylate	100 in 1 BOTTLE	TABLET	100		1
53002-3249-3	Amlodipine Besylate	30 in 1 BOTTLE	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-3249	AMLODIPINE BESYLATE TABLET [RPK PHARMACEUTICALS, INC.]	1	Legacy NDC, 2 package rows	20201225_b28ff8d2-c7d2-4043-b537-78463abd765f.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	ST. MARY'S MEDICAL PARK PHARMACY	b2d5cccd-e5ff-2909-e053-2a95a90a9773	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	988e5acb-356e-4116-b6db-ab8468ed7234	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	743ae641-14e1-456b-80e6-c6f7d621e969	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Northwind Health Company, LLC	0de6a6d0-a114-e114-e063-6394a90a34dd	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	41af64c4-b788-d827-e063-6394a90a9157	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	3e0fbf93-cc64-4fa5-b586-c2020614c884	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Direct_Rx	0c7d1f99-dfe0-7041-e063-6294a90a9705	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Redpharm Drug	fc61eee9-ee15-9078-e053-6394a90a22f4	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Quality Care Products, LLC	a75e4797-6b7f-4366-9105-79d6877adac5	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	699d3ba2-a342-4e3d-b8ad-c14e0df64dfe	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	da4e36d3-1ddc-4350-9a00-86975e523f75	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	b1151904-5085-49bd-94ec-cb2894f4eb10	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	b4cc6d7e-923b-e81c-e053-2995a90a0731	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Direct_Rx	094498f2-11d9-2a05-e063-6294a90ab2e1	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	5a67bbdc-ac1f-4778-bbdc-929df140b7f5	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	52daa759-3327-461a-8cfc-3c6253df91ec	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	5c50c3fe-afe5-459e-95c0-c9af4cbb6909	2023-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Unichem Pharmaceuticals (USA), Inc.	a516b336-8f60-4b86-8921-c7d6c07629f2	2022-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d6	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	c2c51ec3-ffb0-4240-b048-a8e424775a76	2021-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245

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
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	b28ff8d2-c7d2-4043-b537-78463abd765f	1
197361	amlodipine 5 MG Oral Tablet	SCD	b28ff8d2-c7d2-4043-b537-78463abd765f	1
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	b28ff8d2-c7d2-4043-b537-78463abd765f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-3249-0	53002324900	100 TABLET in 1 BOTTLE (53002-3249-0)	100 tablet	2019-01-01	0000-00-00	No	No	Current
53002-3249-3	53002324903	30 TABLET in 1 BOTTLE (53002-3249-3)	30 tablet	2019-01-01	0000-00-00	No	No	Current