Amlodipine Besylate

Product NDC
68180-720
11-digit product format
681800720
Labeler code
68180
Product ID
68180-720_99ab6bdc-6207-4886-8f2f-f0ed62622b89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078043
Marketing category
ANDA
Marketing start
2018-08-15
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68180-720DDiscontinued by firm2026-08-17
excluded packagepackage68180-72068180-720-03DDiscontinued by firm2026-08-17
excluded packagepackage68180-72068180-720-09DDiscontinued by firm2026-08-17

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078043-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-12
A078043-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-12
A078043-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078043-001AB
A078043-002AB
A078043-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-12caaa826d4ba7…
2026-08-18 06:07:402026-07A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-12caaa826d4ba7…
2026-08-18 06:07:402026-07A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-121e350fbaab3a…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078043-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078043-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078043-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078043-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078043-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078043-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078043-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078043-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078043-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-001BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-002BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-003BX12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-001BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-002BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-003BX15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-001BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-002BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-003BX1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078043-001BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078043-002BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078043-003BX1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-001BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-002BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-003BX179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-001BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-002BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-003BX1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078043-001AB11e350fbaab3a…

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
68180-720-03Amlodipine Besylate1000 in 1 BOTTLETABLET100029
68180-720-09Amlodipine Besylate90 in 1 BOTTLETABLET9029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-720-03EA - Each68180-720a3658923-aa92-4652-89cd-5df1752f1eec12018-11-06
68180-720-09EA - Each68180-7201e449c7b-8518-4156-a9d2-d22306d15e6e12019-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPAMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-720AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]26Legacy NDC, 2 package rows20250508_003dd1ec-16f8-4f96-b6a8-c4689d35892a.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATELupin Pharmaceuticals, Inc.003dd1ec-16f8-4f96-b6a8-c4689d35892a2026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
ndc (product): 68180-720
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.1df35c9b-0cd8-41f4-b9d4-8f51ba57b3e02026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.a6635bb3-b8d5-4046-ac56-27af9bac877e2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
Amlodipine BesylateAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.2437a130-d544-6db4-e063-6394a90a0d4d2025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LPf18148f9-42b2-43dc-9cf8-212d9121dc5f2024-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions91e11ca6-05fb-47be-bd40-f8649a35d47d2024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions3bd019d3-b58c-44ab-9190-606a0af5e9b62024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack49d69d27-2a75-4a07-bfb9-24f8af8531382024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN003dd1ec-16f8-4f96-b6a8-c4689d35892a29
308136amLODIPine besylate 2.5 MG Oral TabletPSN003dd1ec-16f8-4f96-b6a8-c4689d35892a29
197361amLODIPine besylate 5 MG Oral TabletPSN003dd1ec-16f8-4f96-b6a8-c4689d35892a29
308135amlodipine 10 MG Oral TabletSCD003dd1ec-16f8-4f96-b6a8-c4689d35892a29
308136amlodipine 2.5 MG Oral TabletSCD003dd1ec-16f8-4f96-b6a8-c4689d35892a29
197361amlodipine 5 MG Oral TabletSCD003dd1ec-16f8-4f96-b6a8-c4689d35892a29
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY003dd1ec-16f8-4f96-b6a8-c4689d35892a29
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY003dd1ec-16f8-4f96-b6a8-c4689d35892a29
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY003dd1ec-16f8-4f96-b6a8-c4689d35892a29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-720-03681800720031000 TABLET in 1 BOTTLE (68180-720-03) 1000 tablet2018-10-310000-00-00NoNoCurrent
68180-720-096818007200990 TABLET in 1 BOTTLE (68180-720-09) 90 tablet2018-08-150000-00-00NoNoCurrent