Amlodipine Besylate

Product NDC
55700-541
Requested package NDC
55700-541-90
11-digit product format
557000541
Labeler code
55700
Product ID
55700-541_7aa1f125-789d-4c41-917b-2e879b430beb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA078925
Marketing category
ANDA
Marketing start
2017-08-11
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55700-54155700-541-90DDiscontinued by firm2026-08-03

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
A078925-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-04
A078925-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-04
A078925-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078925-001AB
A078925-002AB
A078925-003AB

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 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078925-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2009-05-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078925-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2009-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078925-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2009-05-044b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078925-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078925-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078925-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078925-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078925-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078925-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078925-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078925-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078925-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078925-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078925-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078925-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078925-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078925-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078925-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078925-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078925-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078925-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078925-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078925-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078925-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078925-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078925-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078925-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078925-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078925-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078925-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078925-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078925-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078925-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078925-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078925-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078925-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078925-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078925-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078925-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078925-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078925-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078925-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078925-001AB14b0b4de00fa7…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.58a67272-c4c7-4e2c-85a5-9d39034d12c32026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.4ad016ec-e158-4325-9f45-4460cf78dd982026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEUnit Dose Solutions, Inc.5467eee5-1519-7859-e063-6294a90afed12026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP61cb7f91-d1f6-40bd-98a3-c461098a20d92026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard Labs6efc0ef6-0424-44fc-a9ea-eb30c3b832392026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATECoupler LLC2904c6e1-2c51-8035-e063-6294a90aa04b2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack72dafc2f-5266-442b-914a-61d1ef1f7ab82026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.d2f66b58-78ec-456b-8397-2120a223827c2026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutionscd305e6e-9107-4d25-9918-8d0d9b9ba1ca2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions50204e86-a345-4d2f-b62f-a548787e197f2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals, Inc.01139e81-a4fa-4e13-acdf-c75c79a1aa9c2026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.1ff04bd2-9926-48a4-9afc-eab0789dba012026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.204f27e9-5041-4677-b313-866ca69abad92026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.6e038d92-09f3-4517-947e-146d007114b82026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATENorthwind Health Company, LLCf2b8274b-d849-6793-e053-2a95a90aa0e82026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATENorthwind Health Company, LLCf32bb322-68d7-a4ca-e053-2995a90aa7b02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEAscend Laboratories, LLC2b0bcb95-dc85-46f7-8b69-ca55cd58b30e2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEQPharma Inc3f74ed2b-4712-4026-ac2c-9239a211dde32025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.47114f60-4151-43d4-ac2d-adc49492a6792025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925
Amlodipine BesylateAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.ac0dd8fb-ebe1-4d02-bd0d-4f979c6e36082025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078925
application number: ANDA078925

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
55700-541-30Amlodipine Besylate30 in 1 BOTTLETABLET3011
55700-541-90Amlodipine Besylate90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-541-30EA - Each55700-541c8e4f7e5-f13e-400d-8c9e-911d3d8fdf4812017-09-11
55700-541-90EA - Each55700-54144af0ae1-f117-43f1-814f-3ff8301c8d7812017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-541AMLODIPINE BESYLATE TABLET [QUALITY CARE PRODUCTS, LLC]11Legacy NDC, 2 package rows20241219_6b7c18ef-3a85-4ae3-9135-7ac30a0dde08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
197361amLODIPine besylate 5 MG Oral TabletPSN6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
308135amlodipine 10 MG Oral TabletSCD6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
197361amlodipine 5 MG Oral TabletSCD6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-541-905570005419090 TABLET in 1 BOTTLE (55700-541-90) 90 tablet2017-08-180000-00-00NoNoCurrent