Amlodipine Besylate

Product NDC: 29300-243
Requested package NDC: 29300-243-03
11-digit product format: 293000243
Labeler code: 29300
Product ID: 29300-243_cb3f3981-8d99-4d65-90cf-2bb6722167b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA203245
Marketing category: ANDA
Marketing start: 2014-03-03
Marketing end: 0000-00-00
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	29300-243	29300-243-03	D	Discontinued by firm		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 · 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	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-243-05	EA - Each	29300-243	8482a1f4-d7ba-43a1-9f15-076b55b7e117	1	2014-07-02
29300-243-10	EA - Each	29300-243	40f6d5a1-80a0-47a1-a062-27a664682639	1	2014-07-02
29300-243-19	EA - Each	29300-243	f7e77ba7-2e09-4b8a-b160-2a2b2ed68b12	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	6
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	6
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	AMLODIPINE BESYLATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	6
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]	1
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]	1

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
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	da3d696b-8db7-4487-be86-c2e8cbfbe749	21
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	da3d696b-8db7-4487-be86-c2e8cbfbe749	21
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	da3d696b-8db7-4487-be86-c2e8cbfbe749	21
308135	amlodipine 10 MG Oral Tablet	SCD	da3d696b-8db7-4487-be86-c2e8cbfbe749	21
308136	amlodipine 2.5 MG Oral Tablet	SCD	da3d696b-8db7-4487-be86-c2e8cbfbe749	21
197361	amlodipine 5 MG Oral Tablet	SCD	da3d696b-8db7-4487-be86-c2e8cbfbe749	21
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	da3d696b-8db7-4487-be86-c2e8cbfbe749	21
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	da3d696b-8db7-4487-be86-c2e8cbfbe749	21
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	da3d696b-8db7-4487-be86-c2e8cbfbe749	21
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	4910c9c2-d290-38c4-e054-00144ff8d46c	6
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	2db18372-0600-480f-8551-533b61415abd	6
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	2db18372-0600-480f-8551-533b61415abd	6
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	4910c9c2-d290-38c4-e054-00144ff8d46c	6
308135	amlodipine 10 MG Oral Tablet	SCD	2db18372-0600-480f-8551-533b61415abd	6
308135	amlodipine 10 MG Oral Tablet	SCD	4910c9c2-d290-38c4-e054-00144ff8d46c	6
197361	amlodipine 5 MG Oral Tablet	SCD	4910c9c2-d290-38c4-e054-00144ff8d46c	6
197361	amlodipine 5 MG Oral Tablet	SCD	2db18372-0600-480f-8551-533b61415abd	6
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	2db18372-0600-480f-8551-533b61415abd	6
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	4910c9c2-d290-38c4-e054-00144ff8d46c	6
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	4910c9c2-d290-38c4-e054-00144ff8d46c	6
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	2db18372-0600-480f-8551-533b61415abd	6
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	48f94245-3a9d-0b7c-e054-00144ff88e88	3
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	48f94245-3a9d-0b7c-e054-00144ff88e88	3
308135	amlodipine 10 MG Oral Tablet	SCD	48f94245-3a9d-0b7c-e054-00144ff88e88	3
308136	amlodipine 2.5 MG Oral Tablet	SCD	48f94245-3a9d-0b7c-e054-00144ff88e88	3
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	48f94245-3a9d-0b7c-e054-00144ff88e88	3
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	48f94245-3a9d-0b7c-e054-00144ff88e88	3
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	c5861dd6-f0cb-449d-9ebe-53c7a76b3d00	2
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	8ed59bcc-5840-f798-e053-2995a90a828b	2
308135	amlodipine 10 MG Oral Tablet	SCD	c5861dd6-f0cb-449d-9ebe-53c7a76b3d00	2
308135	amlodipine 10 MG Oral Tablet	SCD	8ed59bcc-5840-f798-e053-2995a90a828b	2
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	8ed59bcc-5840-f798-e053-2995a90a828b	2
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	c5861dd6-f0cb-449d-9ebe-53c7a76b3d00	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-243-03	29300024303	300 TABLET in 1 BOTTLE, PLASTIC (29300-243-03)	300 tablet	2014-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine Besylate	Unichem Pharmaceuticals (USA), Inc.	2023-02-22	HUMAN PRESCRIPTION DRUG LABEL	14
Amlodipine Besylate	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	3
Amlodipine Besylate	Bryant Ranch Prepack	2022-02-14	HUMAN PRESCRIPTION DRUG LABEL	2
Amlodipine Besylate	Bryant Ranch Prepack	2022-02-09	HUMAN PRESCRIPTION DRUG LABEL	100
Amlodipine Besylate	NuCare Pharmaceuticals,Inc.	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	2
Amlodipine Besylate	Bryant Ranch Prepack	2021-12-23	HUMAN PRESCRIPTION DRUG LABEL	5
AMLODIPINE BESYLATE	DIRECT RX	2021-12-07	HUMAN PRESCRIPTION DRUG LABEL	6
Amlodipine Besylate	A-S Medication Solutions	2021-06-18	HUMAN PRESCRIPTION DRUG LABEL	21
Amlodipine Besylate	Preferred Pharmaceutical Inc.	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	6
Amlodipine Besylate	NuCare Pharmaceuticals, Inc.	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	4
AMLODIPINE BESYLATE	DIRECT RX	2021-01-18	HUMAN PRESCRIPTION DRUG LABEL	3
Amlodipine Besylate	RPK Pharmaceuticals, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	6
Amlodipine Besylate	St. Mary's Medical Park Pharmacy	2020-05-06	HUMAN PRESCRIPTION DRUG LABEL	1
Amlodipine Besylate	REMEDYREPACK INC.	2020-04-06	HUMAN PRESCRIPTION DRUG LABEL	4
Amlodipine Besylate	Proficient Rx LP	2020-02-01	HUMAN PRESCRIPTION DRUG LABEL	4
AMLODIPINE BESYLATE	Direct_Rx	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	2
Amlodipine Besylate	KAISER FOUNDATION HOSPITALS	2018-11-26	HUMAN PRESCRIPTION DRUG LABEL	2
Amlodipine Besylate	NCS HealthCare of KY, Inc dba Vangard Labs	2018-05-31	HUMAN PRESCRIPTION DRUG LABEL	4