FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
71335-1887
11-digit product format
713351887
Labeler code
71335
Product ID
71335-1887_42be4afb-caa4-4ad4-b489-bd42b182ea9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077516
Marketing category
ANDA
Marketing start
2011-04-15
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
A077516-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-11
A077516-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-11
A077516-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-11

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 22:54:322026-06A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-11a50c72e98297…
2026-08-01 22:54:322026-06A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-11a50c72e98297…
2026-08-01 22:54:322026-06A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-11a50c72e98297…

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 BESYLATEBryant Ranch Prepackcb3da88f-cee0-4c22-9760-a50edc8fc1402023-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077516
application number: ANDA077516
ndc (product): 71335-1887

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb3da88f-cee0-4c22-9760-a50edc8fc140Available 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
71335-1887-1AMLODIPINE BESYLATE30 in 1 BOTTLETABLET30102
71335-1887-2AMLODIPINE BESYLATE90 in 1 BOTTLETABLET90102
71335-1887-3AMLODIPINE BESYLATE60 in 1 BOTTLETABLET60102
71335-1887-4AMLODIPINE BESYLATE120 in 1 BOTTLETABLET120102
71335-1887-5AMLODIPINE BESYLATE100 in 1 BOTTLETABLET100102
71335-1887-6AMLODIPINE BESYLATE800 in 1 BOTTLETABLET800102
71335-1887-7AMLODIPINE BESYLATE1000 in 1 BOTTLETABLET1000102
71335-1887-8AMLODIPINE BESYLATE180 in 1 BOTTLETABLET180102
71335-1887-9AMLODIPINE BESYLATE10 in 1 BOTTLETABLET10102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1887AMLODIPINE BESYLATE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 9 package rows20230328_cb3da88f-cee0-4c22-9760-a50edc8fc140.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNcb3da88f-cee0-4c22-9760-a50edc8fc140102
308135amlodipine 10 MG Oral TabletSCDcb3da88f-cee0-4c22-9760-a50edc8fc140102
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYcb3da88f-cee0-4c22-9760-a50edc8fc140102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1887-17133518870130 TABLET in 1 BOTTLE (71335-1887-1) 30 tablet2021-08-090000-00-00NoNoCurrent
71335-1887-27133518870290 TABLET in 1 BOTTLE (71335-1887-2) 90 tablet2021-07-270000-00-00NoNoCurrent
71335-1887-37133518870360 TABLET in 1 BOTTLE (71335-1887-3) 60 tablet2021-08-240000-00-00NoNoCurrent
71335-1887-471335188704120 TABLET in 1 BOTTLE (71335-1887-4) 120 tablet2022-02-150000-00-00NoNoCurrent
71335-1887-571335188705100 TABLET in 1 BOTTLE (71335-1887-5) 100 tablet2021-08-030000-00-00NoNoCurrent
71335-1887-671335188706800 TABLET in 1 BOTTLE (71335-1887-6) 800 tablet2022-02-150000-00-00NoNoCurrent
71335-1887-7713351887071000 TABLET in 1 BOTTLE (71335-1887-7) 1000 tablet2022-02-150000-00-00NoNoCurrent
71335-1887-871335188708180 TABLET in 1 BOTTLE (71335-1887-8) 180 tablet2022-02-150000-00-00NoNoCurrent
71335-1887-97133518870910 TABLET in 1 BOTTLE (71335-1887-9) 10 tablet2022-02-150000-00-00NoNoCurrent