Amlodipine besylate

Product NDC: 71335-0843
Requested package NDC: 71335-0843-2
11-digit product format: 713350843
Labeler code: 71335
Product ID: 71335-0843_d64fca06-e908-4f92-a45e-ffa7121bc712
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077955
Marketing category: ANDA
Marketing start: 2007-11-02
Substance: AMLODIPINE BESYLATE
Active strength: 10 mg/1
Pharmacologic classes: 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: 2026-12-31
Current FDA listing: Yes

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	71335-0843	71335-0843-2	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 · 14 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`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
A077955-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28
A077955-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28
A077955-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077955-001	AB
A077955-002	AB
A077955-003	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	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077955-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077955-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077955-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-08-28	`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	A077955-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077955-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077955-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077955-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077955-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077955-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077955-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077955-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077955-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077955-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077955-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077955-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077955-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077955-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077955-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077955-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077955-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077955-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077955-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077955-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077955-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077955-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077955-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077955-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077955-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077955-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077955-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077955-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077955-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077955-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077955-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077955-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077955-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077955-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077955-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077955-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077955-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077955-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077955-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077955-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amlodipine besylate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308135	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
f968393f-47d2-4c16-b34f-93a9d61adb9e	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
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, Related label table
NDC	Effective	Related label
71335-0843-1	2024-05-15	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
71335-0843-2	2024-05-15	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
71335-0843-3	2024-05-15	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
71335-0843-4	2024-05-15	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
71335-0843-5	2024-05-15	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
71335-0843-6	2024-05-15	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
71335-0843-7	2024-05-15	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
71335-0843-8	2024-05-15	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
71335-0843-9	2024-05-15	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
71335-0843-1	2024-01-30	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
71335-0843-2	2024-01-30	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
71335-0843-3	2024-01-30	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
71335-0843-4	2024-01-30	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
71335-0843-5	2024-01-30	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
71335-0843-6	2024-01-30	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
71335-0843-7	2024-01-30	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
71335-0843-8	2024-01-30	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
71335-0843-9	2024-01-30	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	SPL version
71335-0843-0	Amlodipine besylate	7 in 1 BOTTLE	TABLET	7	101
71335-0843-1	Amlodipine besylate	30 in 1 BOTTLE	TABLET	30	101
71335-0843-2	Amlodipine besylate	90 in 1 BOTTLE	TABLET	90	101
71335-0843-3	Amlodipine besylate	60 in 1 BOTTLE	TABLET	60	101
71335-0843-4	Amlodipine besylate	120 in 1 BOTTLE	TABLET	120	101
71335-0843-5	Amlodipine besylate	100 in 1 BOTTLE	TABLET	100	101
71335-0843-6	Amlodipine besylate	800 in 1 BOTTLE	TABLET	800	101
71335-0843-7	Amlodipine besylate	1000 in 1 BOTTLE	TABLET	1000	101
71335-0843-8	Amlodipine besylate	180 in 1 BOTTLE	TABLET	180	101
71335-0843-9	Amlodipine besylate	10 in 1 BOTTLE	TABLET	10	101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0843	AMLODIPINE BESYLATE TABLET [BRYANT RANCH PREPACK]	101	Current NDC, Legacy NDC, 10 package rows	20240517_f968393f-47d2-4c16-b34f-93a9d61adb9e.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	Legacy Pharmaceutical Packaging, LLC	2cdd0da9-eea6-45e0-b0b7-35413a168a4f	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077955 application number: ANDA077955
Amlodipine besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	c3742b31-11f6-4c11-98e3-75916a1982d4	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077955 application number: ANDA077955
Amlodipine besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	f968393f-47d2-4c16-b34f-93a9d61adb9e	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077955 application number: ANDA077955 ndc (package): 71335-0843-2 ndc (product): 71335-0843 ndc11 (package): 71335084302
Amlodipine besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	498a9b21-34b9-4373-930b-5ed43201a345	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077955 application number: ANDA077955
Amlodipine besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	e8958997-f098-44ce-8c21-b7064d1a962e	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077955 application number: ANDA077955
Amlodipine besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee1	2023-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077955 application number: ANDA077955
Amlodipine besylate	AMLODIPINE BESYLATE	Exelan Pharmaceuticals, Inc.	efd9eda5-f497-45a3-ae13-dee729add999	2023-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077955 application number: ANDA077955
Amlodipine Besylate	AMLODIPINE BESYLATE	Cipla USA Inc.	0c8d6b2f-3e4a-47a2-80e2-a34dcb337555	2020-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077955 application number: ANDA077955
Amlodipine besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	17e6d552-7528-4597-9498-104cb04f32e7	2017-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077955 application number: ANDA077955

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	f968393f-47d2-4c16-b34f-93a9d61adb9e	101
308135	amlodipine 10 MG Oral Tablet	SCD	f968393f-47d2-4c16-b34f-93a9d61adb9e	101
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	f968393f-47d2-4c16-b34f-93a9d61adb9e	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0843-2	71335084302	90 TABLET in 1 BOTTLE (71335-0843-2)	90 tablet	2022-02-23	0000-00-00	No	No	Current