Amlodipine Besylate

Product NDC: 65841-620
11-digit product format: 658410620
Labeler code: 65841
Product ID: 65841-620_cb1a9e7c-aa86-4596-bc0d-86d8b5750963
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA078226
Marketing category: ANDA
Marketing start: 2007-09-21
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 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
A078226-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09
A078226-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09
A078226-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078226-001	AB
A078226-002	AB
A078226-003	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	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078226-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078226-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078226-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-09	`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	A078226-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078226-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078226-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078226-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078226-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078226-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078226-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078226-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078226-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078226-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078226-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078226-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078226-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078226-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078226-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078226-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078226-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078226-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078226-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078226-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078226-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078226-001	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	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
cacb3551-c579-41cb-bed6-4b4d8b0644fc	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65841-620-01	Amlodipine Besylate	100 in 1 BOTTLE	TABLET	100	13
65841-620-05	Amlodipine Besylate	500 in 1 BOTTLE	TABLET	500	13
65841-620-16	Amlodipine Besylate	90 in 1 BOTTLE	TABLET	90	13
65841-620-77	Amlodipine Besylate	10 in 1 CARTON	TABLET	10	13
65841-620-77	Amlodipine Besylate	10 in 1 BLISTER PACK	TABLET	10	13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]	5
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-620	AMLODIPINE BESYLATE TABLET [ZYDUS LIFESCIENCES LIMITED]	13	Current NDC, Legacy NDC, 5 package rows	20241127_cacb3551-c579-41cb-bed6-4b4d8b0644fc.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	Safecor Health LLC	572bc798-c3d9-4fe2-98be-8e1913bda8f3	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078226 application number: ANDA078226
Amlodipine Besylate	AMLODIPINE BESYLATE	Cardinal Health 107, LLC	a74239bf-4684-424c-ba4e-6087e363265b	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078226 application number: ANDA078226
Amlodipine Besylate	AMLODIPINE BESYLATE	Major Pharmaceuticals	edf9b22c-e37e-4b4e-8a64-20bb036c7d2d	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078226 application number: ANDA078226
Amlodipine Besylate	AMLODIPINE BESYLATE	Zydus Lifesciences Limited	cacb3551-c579-41cb-bed6-4b4d8b0644fc	2024-11-25		Exact identifier application applno (ANDA): 078226 application number: ANDA078226 ndc (product): 65841-620
Amlodipine Besylate	AMLODIPINE BESYLATE	Zydus Pharmaceuticals USA Inc.	fda0739d-b355-478c-acae-8f773a3ec4b3	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078226 application number: ANDA078226

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	cacb3551-c579-41cb-bed6-4b4d8b0644fc	13
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	cacb3551-c579-41cb-bed6-4b4d8b0644fc	13
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	cacb3551-c579-41cb-bed6-4b4d8b0644fc	13
308135	amlodipine 10 MG Oral Tablet	SCD	cacb3551-c579-41cb-bed6-4b4d8b0644fc	13
308136	amlodipine 2.5 MG Oral Tablet	SCD	cacb3551-c579-41cb-bed6-4b4d8b0644fc	13
197361	amlodipine 5 MG Oral Tablet	SCD	cacb3551-c579-41cb-bed6-4b4d8b0644fc	13
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	cacb3551-c579-41cb-bed6-4b4d8b0644fc	13
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	cacb3551-c579-41cb-bed6-4b4d8b0644fc	13
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	cacb3551-c579-41cb-bed6-4b4d8b0644fc	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-620-01	65841062001	100 TABLET in 1 BOTTLE (65841-620-01)	100 tablet	2007-09-21	0000-00-00	No	No	Current
65841-620-05	65841062005	500 TABLET in 1 BOTTLE (65841-620-05)	500 tablet	2007-09-21	0000-00-00	No	No	Current
65841-620-16	65841062016	90 TABLET in 1 BOTTLE (65841-620-16)	90 tablet	2007-09-21	0000-00-00	No	No	Current
65841-620-77	65841062077	10 BLISTER PACK in 1 CARTON (65841-620-77) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2007-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMLODIPINE Besylate Tablets	Zydus Lifesciences Limited	2024-11-25	HUMAN PRESCRIPTION DRUG LABEL	13