Amlodipine Besylate

Product NDC: 50090-5354
11-digit product format: 500905354
Labeler code: 50090
Product ID: 50090-5354_ccb87248-13c9-455b-8e8e-3f21fd381cf8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078043
Marketing category: ANDA
Marketing start: 2018-08-15
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

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 · 6 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
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	50090-5354-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-5354-1	`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	50090-5354-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-5354-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078043-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-12
A078043-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-12
A078043-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078043-001	AB
A078043-002	AB
A078043-003	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	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	BX	2007-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	BX	2007-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	BX	2007-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	BX	2007-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	BX	2007-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	BX	2007-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	BX	2007-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	BX	2007-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	BX	2007-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	BX	2007-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	BX	2007-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	BX	2007-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	BX	2007-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	BX	2007-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	BX	2007-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	BX	2007-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	BX	2007-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	BX	2007-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-12	`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	A078043-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078043-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078043-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078043-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078043-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078043-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078043-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078043-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078043-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078043-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078043-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078043-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078043-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078043-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078043-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078043-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078043-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078043-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078043-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078043-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078043-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078043-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078043-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078043-003	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078043-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078043-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078043-003	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078043-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078043-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078043-003	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078043-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078043-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078043-003	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078043-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078043-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078043-003	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078043-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078043-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078043-003	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078043-001	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	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
3bd019d3-b58c-44ab-9190-606a0af5e9b6	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
50090-5354-0	2023-02-07	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
50090-5354-1	2023-02-07	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
50090-5354-0	2023-01-30	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
50090-5354-1	2023-01-30	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
50090-5354-0	Amlodipine Besylate	30 in 1 BOTTLE	TABLET	30	8
50090-5354-1	Amlodipine Besylate	90 in 1 BOTTLE	TABLET	90	8
50090-5354-2	Amlodipine Besylate	100 in 1 BOTTLE	TABLET	100	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5354-0	EA - Each	50090-5354	f0fe0f8e-ff81-49c2-91d0-9c2f3b061368	1	2022-12-07
50090-5354-1	EA - Each	50090-5354	ef21cd35-d711-492b-a17f-ded1624d9ee8	1	2022-01-06
50090-5354-2	EA - Each	50090-5354	a5ccc83e-d86e-4ed0-9ecb-e22a5d2dd1c3	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5354	AMLODIPINE BESYLATE TABLET [A-S MEDICATION SOLUTIONS]	8	Current NDC, Legacy NDC, 3 package rows	20241015_3bd019d3-b58c-44ab-9190-606a0af5e9b6.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	Lupin Pharmaceuticals, Inc.	003dd1ec-16f8-4f96-b6a8-c4689d35892a	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078043 application number: ANDA078043
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	1df35c9b-0cd8-41f4-b9d4-8f51ba57b3e0	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078043 application number: ANDA078043
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	a6635bb3-b8d5-4046-ac56-27af9bac877e	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078043 application number: ANDA078043
Amlodipine Besylate	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	2437a130-d544-6db4-e063-6394a90a0d4d	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078043 application number: ANDA078043
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	f18148f9-42b2-43dc-9cf8-212d9121dc5f	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078043 application number: ANDA078043
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	91e11ca6-05fb-47be-bd40-f8649a35d47d	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078043 application number: ANDA078043
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	3bd019d3-b58c-44ab-9190-606a0af5e9b6	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078043 application number: ANDA078043 ndc (product): 50090-5354
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	49d69d27-2a75-4a07-bfb9-24f8af853138	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078043 application number: ANDA078043

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	3bd019d3-b58c-44ab-9190-606a0af5e9b6	8
308135	amlodipine 10 MG Oral Tablet	SCD	3bd019d3-b58c-44ab-9190-606a0af5e9b6	8
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	3bd019d3-b58c-44ab-9190-606a0af5e9b6	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5354-0	50090535400	30 TABLET in 1 BOTTLE (50090-5354-0)	30 tablet	2020-11-11	0000-00-00	No	No	Current
50090-5354-1	50090535401	90 TABLET in 1 BOTTLE (50090-5354-1)	90 tablet	2020-11-11	0000-00-00	No	No	Current
50090-5354-2	50090535402	100 TABLET in 1 BOTTLE (50090-5354-2)	100 tablet	2024-10-10		No	No	Current