Amlodipine Besylate

Product NDC: 67877-197
11-digit product format: 678770197
Labeler code: 67877
Product ID: 67877-197_9fb4b641-2b16-4bcb-89de-d8d5893916ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA078925
Marketing category: ANDA
Marketing start: 2010-10-20
Substance: AMLODIPINE BESYLATE
Active strength: 2.5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078925-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04
A078925-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04
A078925-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078925-001	AB
A078925-002	AB
A078925-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078925-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078925-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078925-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078925-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078925-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078925-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078925-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078925-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078925-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078925-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078925-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078925-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078925-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078925-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078925-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078925-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078925-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078925-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078925-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078925-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078925-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078925-001	AB	1	`1e350fbaab3a…`

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	2.5 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197361	Internal RxNorm lookup
308135	Internal RxNorm lookup
308136	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
3f4703c0-0b9e-41a0-8b70-da26683d9ed2	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
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
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
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67877-197-05	Amlodipine Besylate	500 in 1 BOTTLE	TABLET	500	20
67877-197-10	Amlodipine Besylate	1000 in 1 BOTTLE	TABLET	1000	20
67877-197-38	Amlodipine Besylate	10 in 1 CARTON	TABLET	10	20
67877-197-38	Amlodipine Besylate	10 in 1 BLISTER PACK	TABLET	10	20
67877-197-90	Amlodipine Besylate	90 in 1 BOTTLE	TABLET	90	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-197-05	EA - Each	67877-197	8c6c1dd8-ea77-404c-83c6-88a2aa506d36	1	2012-07-24
67877-197-10	EA - Each	67877-197	61eb2cf4-a5fe-48c2-8e27-ba9f184e29a8	1	2012-07-24
67877-197-90	EA - Each	67877-197	fd761488-92e6-43fb-982a-0e7a1f6f1792	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]	6
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]	6
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]	6
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-197	AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]	20	Current NDC, Legacy NDC, 5 package rows	20240622_3f4703c0-0b9e-41a0-8b70-da26683d9ed2.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 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	6efc0ef6-0424-44fc-a9ea-eb30c3b83239	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	58a67272-c4c7-4e2c-85a5-9d39034d12c3	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	4ad016ec-e158-4325-9f45-4460cf78dd98	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Unit Dose Solutions, Inc.	5467eee5-1519-7859-e063-6294a90afed1	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	61cb7f91-d1f6-40bd-98a3-c461098a20d9	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Coupler LLC	2904c6e1-2c51-8035-e063-6294a90aa04b	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	72dafc2f-5266-442b-914a-61d1ef1f7ab8	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	d2f66b58-78ec-456b-8397-2120a223827c	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	cd305e6e-9107-4d25-9918-8d0d9b9ba1ca	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	50204e86-a345-4d2f-b62f-a548787e197f	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals, Inc.	01139e81-a4fa-4e13-acdf-c75c79a1aa9c	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	1ff04bd2-9926-48a4-9afc-eab0789dba01	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	204f27e9-5041-4677-b313-866ca69abad9	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	6e038d92-09f3-4517-947e-146d007114b8	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Northwind Health Company, LLC	f2b8274b-d849-6793-e053-2a95a90aa0e8	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Northwind Health Company, LLC	f32bb322-68d7-a4ca-e053-2995a90aa7b0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Ascend Laboratories, LLC	2b0bcb95-dc85-46f7-8b69-ca55cd58b30e	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	QPharma Inc	3f74ed2b-4712-4026-ac2c-9239a211dde3	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	47114f60-4151-43d4-ac2d-adc49492a679	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ac0dd8fb-ebe1-4d02-bd0d-4f979c6e3608	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925

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	921096ab-589a-4821-8d91-a6319f4a559a	35
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	921096ab-589a-4821-8d91-a6319f4a559a	35
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	921096ab-589a-4821-8d91-a6319f4a559a	35
308135	amlodipine 10 MG Oral Tablet	SCD	921096ab-589a-4821-8d91-a6319f4a559a	35
308136	amlodipine 2.5 MG Oral Tablet	SCD	921096ab-589a-4821-8d91-a6319f4a559a	35
197361	amlodipine 5 MG Oral Tablet	SCD	921096ab-589a-4821-8d91-a6319f4a559a	35
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	921096ab-589a-4821-8d91-a6319f4a559a	35
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	921096ab-589a-4821-8d91-a6319f4a559a	35
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	921096ab-589a-4821-8d91-a6319f4a559a	35
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	3f4703c0-0b9e-41a0-8b70-da26683d9ed2	20
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	3f4703c0-0b9e-41a0-8b70-da26683d9ed2	20
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	3f4703c0-0b9e-41a0-8b70-da26683d9ed2	20
308135	amlodipine 10 MG Oral Tablet	SCD	3f4703c0-0b9e-41a0-8b70-da26683d9ed2	20
308136	amlodipine 2.5 MG Oral Tablet	SCD	3f4703c0-0b9e-41a0-8b70-da26683d9ed2	20
197361	amlodipine 5 MG Oral Tablet	SCD	3f4703c0-0b9e-41a0-8b70-da26683d9ed2	20
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	3f4703c0-0b9e-41a0-8b70-da26683d9ed2	20
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	3f4703c0-0b9e-41a0-8b70-da26683d9ed2	20
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	3f4703c0-0b9e-41a0-8b70-da26683d9ed2	20
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	47f228e9-4a34-4d14-988d-b06af90124b9	16
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	47f228e9-4a34-4d14-988d-b06af90124b9	16
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	47f228e9-4a34-4d14-988d-b06af90124b9	16
308135	amlodipine 10 MG Oral Tablet	SCD	47f228e9-4a34-4d14-988d-b06af90124b9	16
308136	amlodipine 2.5 MG Oral Tablet	SCD	47f228e9-4a34-4d14-988d-b06af90124b9	16
197361	amlodipine 5 MG Oral Tablet	SCD	47f228e9-4a34-4d14-988d-b06af90124b9	16
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	47f228e9-4a34-4d14-988d-b06af90124b9	16
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	47f228e9-4a34-4d14-988d-b06af90124b9	16
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	47f228e9-4a34-4d14-988d-b06af90124b9	16
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	4ad016ec-e158-4325-9f45-4460cf78dd98	14
308136	amlodipine 2.5 MG Oral Tablet	SCD	4ad016ec-e158-4325-9f45-4460cf78dd98	14
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	4ad016ec-e158-4325-9f45-4460cf78dd98	14
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	6cf5ece4-4d4e-478e-be8f-bd198c6edc5d	11
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	6cf5ece4-4d4e-478e-be8f-bd198c6edc5d	11
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	6cf5ece4-4d4e-478e-be8f-bd198c6edc5d	11
308135	amlodipine 10 MG Oral Tablet	SCD	6cf5ece4-4d4e-478e-be8f-bd198c6edc5d	11
308136	amlodipine 2.5 MG Oral Tablet	SCD	6cf5ece4-4d4e-478e-be8f-bd198c6edc5d	11
197361	amlodipine 5 MG Oral Tablet	SCD	6cf5ece4-4d4e-478e-be8f-bd198c6edc5d	11
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	6cf5ece4-4d4e-478e-be8f-bd198c6edc5d	11
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	6cf5ece4-4d4e-478e-be8f-bd198c6edc5d	11
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	6cf5ece4-4d4e-478e-be8f-bd198c6edc5d	11
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	1ff04bd2-9926-48a4-9afc-eab0789dba01	5
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	1488378b-d1bb-452e-a287-09019472157a	5
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	ced6d26e-8c54-4808-88b6-446344f4acd0	5
308136	amlodipine 2.5 MG Oral Tablet	SCD	1ff04bd2-9926-48a4-9afc-eab0789dba01	5
308136	amlodipine 2.5 MG Oral Tablet	SCD	1488378b-d1bb-452e-a287-09019472157a	5
308136	amlodipine 2.5 MG Oral Tablet	SCD	ced6d26e-8c54-4808-88b6-446344f4acd0	5
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	ced6d26e-8c54-4808-88b6-446344f4acd0	5
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	1ff04bd2-9926-48a4-9afc-eab0789dba01	5
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	1488378b-d1bb-452e-a287-09019472157a	5
898342	amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral Capsule	PSN	b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719	3
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719	3
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	00a037f6-b17f-4d21-9a9a-0e682f68d483	3
898342	amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule	SCD	b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719	3
308136	amlodipine 2.5 MG Oral Tablet	SCD	b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719	3
308136	amlodipine 2.5 MG Oral Tablet	SCD	00a037f6-b17f-4d21-9a9a-0e682f68d483	3
898342	amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral Capsule	SY	b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719	3
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719	3
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	00a037f6-b17f-4d21-9a9a-0e682f68d483	3
898342	Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule	SY	b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719	3
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	2904c6e1-2c51-8035-e063-6294a90aa04b	2
308136	amlodipine 2.5 MG Oral Tablet	SCD	2904c6e1-2c51-8035-e063-6294a90aa04b	2
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	2904c6e1-2c51-8035-e063-6294a90aa04b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-197-05	67877019705	500 TABLET in 1 BOTTLE (67877-197-05)	500 tablet	2010-10-20	0000-00-00	No	No	Current
67877-197-10	67877019710	1000 TABLET in 1 BOTTLE (67877-197-10)	1000 tablet	2010-10-20	0000-00-00	No	No	Current
67877-197-38	67877019738	10 BLISTER PACK in 1 CARTON (67877-197-38) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2010-10-20	0000-00-00	No	No	Current
67877-197-90	67877019790	90 TABLET in 1 BOTTLE (67877-197-90)	90 tablet	2010-10-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine Besylate	REMEDYREPACK INC.	2026-07-16	HUMAN PRESCRIPTION DRUG LABEL	15
Amlodipine Besylate	Coupler LLC	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	2
Amlodipine Besylate	Preferred Pharmaceuticals Inc.	2026-02-23	HUMAN PRESCRIPTION DRUG LABEL	5
Amlodipine Besylate	PD-Rx Pharmaceuticals, Inc.	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	26
Amlodipine Besylate	Bryant Ranch Prepack	2025-09-29	HUMAN PRESCRIPTION DRUG LABEL	11
Amlodipine Besylate	A-S Medication Solutions	2025-04-09	Human Prescription Drug Label	35
Amlodipine Besylate	A-S Medication Solutions	2025-04-02	Human Prescription Drug Label	3
AMLODIPINE BESYLATE	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	3
Amlodipine Besylate	NCS HealthCare of KY, LLC dba Vangard Labs	2025-01-16	HUMAN PRESCRIPTION DRUG LABEL	16
Amlodipine Besylate	Ascend Laboratories, LLC \| Alkem Laboratories Limited \| VKT Pharma Private Limited	2024-06-21	Human Prescription Drug Label	20
Amlodipine Besylate	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	5
Amlodipine Besylate	Proficient Rx LP	2023-06-01	HUMAN PRESCRIPTION DRUG LABEL	5
Amlodipine Besylate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-02	HUMAN PRESCRIPTION DRUG LABEL	2
Amlodipine Besylate	Quality Care Products, LLC	2021-04-14	Human Prescription Drug Label	2
Amlodipine Besylate	NuCare Pharmaceuticals,Inc.	2021-03-24	HUMAN PRESCRIPTION DRUG LABEL	3
Amlodipine Besylate	Bryant Ranch Prepack	2020-10-16	Human Prescription Drug Label	3
Amlodipine Besylate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-08-13	HUMAN PRESCRIPTION DRUG LABEL	2