Amlodipine Besylate

Product NDC
65841-622
11-digit product format
658410622
Labeler code
65841
Product ID
65841-622_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
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078226-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-09
A078226-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-09
A078226-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078226-001AB
A078226-002AB
A078226-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-098072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078226-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078226-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078226-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078226-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078226-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078226-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078226-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078226-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078226-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078226-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078226-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078226-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078226-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078226-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078226-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078226-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078226-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078226-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078226-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078226-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078226-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078226-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078226-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078226-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078226-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078226-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078226-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078226-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078226-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078226-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078226-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078226-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078226-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078226-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078226-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078226-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078226-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078226-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078226-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078226-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine Besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864V2Q084HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197361Internal RxNorm lookup
308135Internal RxNorm lookup
308136Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cacb3551-c579-41cb-bed6-4b4d8b0644fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-622-01Amlodipine Besylate100 in 1 BOTTLETABLET10013
65841-622-05Amlodipine Besylate500 in 1 BOTTLETABLET50013
65841-622-16Amlodipine Besylate90 in 1 BOTTLETABLET9013
65841-622-77Amlodipine Besylate10 in 1 CARTONTABLET1013
65841-622-77Amlodipine Besylate10 in 1 BLISTER PACKTABLET1013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]5
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [CADILA HEALTHCARE LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-622AMLODIPINE BESYLATE TABLET [ZYDUS LIFESCIENCES LIMITED]13Current NDC, Legacy NDC, 5 package rows20241127_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATESafecor Health LLC572bc798-c3d9-4fe2-98be-8e1913bda8f32026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078226
application number: ANDA078226
Amlodipine BesylateAMLODIPINE BESYLATECardinal Health 107, LLCa74239bf-4684-424c-ba4e-6087e363265b2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078226
application number: ANDA078226
Amlodipine BesylateAMLODIPINE BESYLATEMajor Pharmaceuticalsedf9b22c-e37e-4b4e-8a64-20bb036c7d2d2025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078226
application number: ANDA078226
Amlodipine BesylateAMLODIPINE BESYLATEZydus Lifesciences Limitedcacb3551-c579-41cb-bed6-4b4d8b0644fc2024-11-25Exact identifier
application applno (ANDA): 078226
application number: ANDA078226
ndc (product): 65841-622
Amlodipine BesylateAMLODIPINE BESYLATEZydus Pharmaceuticals USA Inc.fda0739d-b355-478c-acae-8f773a3ec4b32024-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078226
application number: ANDA078226

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNcacb3551-c579-41cb-bed6-4b4d8b0644fc13
308136amLODIPine besylate 2.5 MG Oral TabletPSNcacb3551-c579-41cb-bed6-4b4d8b0644fc13
197361amLODIPine besylate 5 MG Oral TabletPSNcacb3551-c579-41cb-bed6-4b4d8b0644fc13
308135amlodipine 10 MG Oral TabletSCDcacb3551-c579-41cb-bed6-4b4d8b0644fc13
308136amlodipine 2.5 MG Oral TabletSCDcacb3551-c579-41cb-bed6-4b4d8b0644fc13
197361amlodipine 5 MG Oral TabletSCDcacb3551-c579-41cb-bed6-4b4d8b0644fc13
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYcacb3551-c579-41cb-bed6-4b4d8b0644fc13
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYcacb3551-c579-41cb-bed6-4b4d8b0644fc13
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYcacb3551-c579-41cb-bed6-4b4d8b0644fc13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-622-0165841062201100 TABLET in 1 BOTTLE (65841-622-01) 100 tablet2007-09-210000-00-00NoNoCurrent
65841-622-0565841062205500 TABLET in 1 BOTTLE (65841-622-05) 500 tablet2007-09-210000-00-00NoNoCurrent
65841-622-166584106221690 TABLET in 1 BOTTLE (65841-622-16) 90 tablet2007-09-210000-00-00NoNoCurrent
65841-622-776584106227710 BLISTER PACK in 1 CARTON (65841-622-77) / 10 TABLET in 1 BLISTER PACK10 blister pack2007-09-210000-00-00NoNoCurrent