Amlodipine Besylate

Product NDC: 67046-1157
Requested package NDC: 67046-1157-3
11-digit product format: 670461157
Labeler code: 67046
Product ID: 67046-1157_5af848c9-d134-84ff-e063-6394a90a9c90
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA078043
Marketing category: ANDA
Marketing start: 2026-09-08
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A078043-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078043-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078043-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-12	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078043-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078043-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078043-003	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Amlodipine Besylate
Listing expiration: 2027-12-31

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
5af8493b-2b73-859c-e063-6394a90a4620	Available on FDA.report

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	Coupler LLC	5af8493b-2b73-859c-e063-6394a90a4620	2026-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078043 application number: ANDA078043 ndc (package): 67046-1157-3 ndc (product): 67046-1157 ndc11 (package): 67046115703
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1157-3	67046115703	30 TABLET in 1 BLISTER PACK (67046-1157-3)	30 tablet	2026-09-08	No	No	Current