FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
0904-6371
11-digit product format
009046371
Labeler code
0904
Product ID
0904-6371_56f23c85-5abd-443b-afcc-fafd8a8c8dab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078226
Marketing category
ANDA
Marketing start
2013-01-20
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078226-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-09a50c72e98297…
2026-08-01 22:54:322026-06A078226-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-09a50c72e98297…
2026-08-01 22:54:322026-06A078226-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078226-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078226-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078226-003AB1a50c72e98297…

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 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
ndc (product): 0904-6371
Amlodipine BesylateAMLODIPINE BESYLATEZydus Lifesciences Limitedcacb3551-c579-41cb-bed6-4b4d8b0644fc2024-11-25Exact identifier
application applno (ANDA): 078226
application number: ANDA078226
Amlodipine BesylateAMLODIPINE BESYLATEZydus Pharmaceuticals USA Inc.fda0739d-b355-478c-acae-8f773a3ec4b32024-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078226
application number: ANDA078226

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
edf9b22c-e37e-4b4e-8a64-20bb036c7d2dAvailable 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
0904-6371-61Amlodipine Besylate1 in 1 BLISTER PACKTABLET16
0904-6371-61Amlodipine Besylate100 in 1 CARTONTABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6371-61EA - Each0904-6371d5cbd6cc-f01d-4f8b-b3ef-cd302cd2a25b12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]5
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]5
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6371AMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20241102_edf9b22c-e37e-4b4e-8a64-20bb036c7d2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNa74239bf-4684-424c-ba4e-6087e363265b18
308136amLODIPine besylate 2.5 MG Oral TabletPSNa74239bf-4684-424c-ba4e-6087e363265b18
197361amLODIPine besylate 5 MG Oral TabletPSNa74239bf-4684-424c-ba4e-6087e363265b18
308135amlodipine 10 MG Oral TabletSCDa74239bf-4684-424c-ba4e-6087e363265b18
308136amlodipine 2.5 MG Oral TabletSCDa74239bf-4684-424c-ba4e-6087e363265b18
197361amlodipine 5 MG Oral TabletSCDa74239bf-4684-424c-ba4e-6087e363265b18
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYa74239bf-4684-424c-ba4e-6087e363265b18
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYa74239bf-4684-424c-ba4e-6087e363265b18
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYa74239bf-4684-424c-ba4e-6087e363265b18
308135amLODIPine besylate 10 MG Oral TabletPSNedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308136amLODIPine besylate 2.5 MG Oral TabletPSNedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
197361amLODIPine besylate 5 MG Oral TabletPSNedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308135amlodipine 10 MG Oral TabletSCDedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308136amlodipine 2.5 MG Oral TabletSCDedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
197361amlodipine 5 MG Oral TabletSCDedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6371-6100904637161100 BLISTER PACK in 1 CARTON (0904-6371-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2013-01-200000-00-00NoNoCurrent