FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
65862-101
11-digit product format
658620101
Labeler code
65862
Product ID
65862-101_7929af8c-f3da-4b86-8388-20bbe247336e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078021
Marketing category
ANDA
Marketing start
2007-07-17
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
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-101UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage65862-10165862-101-91UNFINISHEDActive or certified unfinished drug listing2026-07-31

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
A078021-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-17
A078021-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-17
A078021-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078021-001AB
A078021-002AB
A078021-003AB

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 22:54:322026-06A078021-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-17a50c72e98297…
2026-08-01 22:54:322026-06A078021-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-17a50c72e98297…
2026-08-01 22:54:322026-06A078021-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078021-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078021-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078021-003AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATEAurobindo Pharma Limitedb6f298ba-2d7e-4a3c-9edb-8b60aba716d62026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078021
application number: ANDA078021
ndc (product): 65862-101

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine Besylate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE2.5 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
b6f298ba-2d7e-4a3c-9edb-8b60aba716d6Available 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
65862-101-05Amlodipine Besylate500 in 1 BOTTLETABLET50020
65862-101-30Amlodipine Besylate30 in 1 BOTTLETABLET3020
65862-101-90Amlodipine Besylate90 in 1 BOTTLETABLET9020
65862-101-99Amlodipine Besylate1000 in 1 BOTTLETABLET100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-101-05EA - Each65862-10159192bb3-91c5-49c2-83d6-1d208b1f6b2912012-07-24
65862-101-90EA - Each65862-1017daabedc-7ae0-440c-9603-bc2c12a23f3012012-07-24
65862-101-99EA - Each65862-101e6757191-e3c0-4176-8bc0-88818a90c43d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [AUROBINDO PHARMA LIMITED]10
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [AUROBINDO PHARMA LIMITED]10
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [AUROBINDO PHARMA LIMITED]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [AUROBINDO PHARMA LIMITED]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [AUROBINDO PHARMA LIMITED]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [AUROBINDO PHARMA LIMITED]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-101AMLODIPINE BESYLATE TABLET [AUROBINDO PHARMA LIMITED]19Current NDC, Legacy NDC, 4 package rows20240426_b6f298ba-2d7e-4a3c-9edb-8b60aba716d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNb6f298ba-2d7e-4a3c-9edb-8b60aba716d620
308136amLODIPine besylate 2.5 MG Oral TabletPSNb6f298ba-2d7e-4a3c-9edb-8b60aba716d620
197361amLODIPine besylate 5 MG Oral TabletPSNb6f298ba-2d7e-4a3c-9edb-8b60aba716d620
308135amlodipine 10 MG Oral TabletSCDb6f298ba-2d7e-4a3c-9edb-8b60aba716d620
308136amlodipine 2.5 MG Oral TabletSCDb6f298ba-2d7e-4a3c-9edb-8b60aba716d620
197361amlodipine 5 MG Oral TabletSCDb6f298ba-2d7e-4a3c-9edb-8b60aba716d620
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYb6f298ba-2d7e-4a3c-9edb-8b60aba716d620
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYb6f298ba-2d7e-4a3c-9edb-8b60aba716d620
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYb6f298ba-2d7e-4a3c-9edb-8b60aba716d620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-101-0565862010105500 TABLET in 1 BOTTLE (65862-101-05) 500 tablet2007-07-170000-00-00NoNoCurrent
65862-101-306586201013030 TABLET in 1 BOTTLE (65862-101-30) 30 tablet2007-07-170000-00-00NoNoCurrent
65862-101-906586201019090 TABLET in 1 BOTTLE (65862-101-90) 90 tablet2007-07-170000-00-00NoNoCurrent
65862-101-91658620101919000 TABLET in 1 BAG (65862-101-91)9000 tablet17-JUL-07Current
65862-101-99658620101991000 TABLET in 1 BOTTLE (65862-101-99) 1000 tablet2007-07-170000-00-00NoNoCurrent