FDA.reportPublic FDA data

Amlodipine besylate and Atorvastatin calcium

Product NDC
59762-6731
Requested package NDC
59762-6731-1
11-digit product format
597626731
Labeler code
59762
Product ID
59762-6731_2b7f54ab-bd35-461c-852a-7041efb60fcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Greenstone LLC
Application
NDA021540
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-04-04
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
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 packagepackage59762-673159762-6731-1DDiscontinued 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 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021540-001CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-30
N021540-002CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-30
N021540-003CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-30
N021540-004CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 80MG BASETABLET / ORALABRLD2004-01-30
N021540-005CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-30
N021540-006CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-30
N021540-007CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-30
N021540-008CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 80MG BASETABLET / ORALABRLD, RS2004-01-30
N021540-009CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-07-29
N021540-010CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-07-29
N021540-011CADUETAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 11 matching rows.

Application-product, TE code table
Application-productTE code
N021540-001AB
N021540-002AB
N021540-003AB
N021540-004AB
N021540-005AB
N021540-006AB
N021540-007AB
N021540-008AB
N021540-009AB
N021540-010AB
N021540-011AB

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 22:54:322026-06N021540-001CADUETEQ 5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-30a50c72e98297…
2026-08-01 22:54:322026-06N021540-002CADUETEQ 5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-30a50c72e98297…
2026-08-01 22:54:322026-06N021540-003CADUETEQ 5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-30a50c72e98297…
2026-08-01 22:54:322026-06N021540-004CADUETEQ 5MG BASE;EQ 80MG BASETABLET / ORALABRLD2004-01-30a50c72e98297…
2026-08-01 22:54:322026-06N021540-005CADUETEQ 10MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-01-30a50c72e98297…
2026-08-01 22:54:322026-06N021540-006CADUETEQ 10MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-01-30a50c72e98297…
2026-08-01 22:54:322026-06N021540-007CADUETEQ 10MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-01-30a50c72e98297…
2026-08-01 22:54:322026-06N021540-008CADUETEQ 10MG BASE;EQ 80MG BASETABLET / ORALABRLD, RS2004-01-30a50c72e98297…
2026-08-01 22:54:322026-06N021540-009CADUETEQ 2.5MG BASE;EQ 10MG BASETABLET / ORALABRLD2004-07-29a50c72e98297…
2026-08-01 22:54:322026-06N021540-010CADUETEQ 2.5MG BASE;EQ 20MG BASETABLET / ORALABRLD2004-07-29a50c72e98297…
2026-08-01 22:54:322026-06N021540-011CADUETEQ 2.5MG BASE;EQ 40MG BASETABLET / ORALABRLD2004-07-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021540-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021540-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N021540-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N021540-004AB1a50c72e98297…
2026-08-01 22:54:322026-06N021540-005AB1a50c72e98297…
2026-08-01 22:54:322026-06N021540-006AB1a50c72e98297…
2026-08-01 22:54:322026-06N021540-007AB1a50c72e98297…
2026-08-01 22:54:322026-06N021540-008AB1a50c72e98297…
2026-08-01 22:54:322026-06N021540-009AB1a50c72e98297…
2026-08-01 22:54:322026-06N021540-010AB1a50c72e98297…
2026-08-01 22:54:322026-06N021540-011AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CaduetAMLODIPINE AND ATORVASTATINPfizer Laboratories Div Pfizer Inc6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b62026-06-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 021540
application number: NDA021540
CaduetAMLODIPINE AND ATORVASTATINViatris Specialty LLC164394b3-d7ba-4bbf-b64b-e2dd15735ea82026-06-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 021540
application number: NDA021540
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINPrasco Laboratories14124e56-77ba-426d-8f5a-dbe42eda1a202026-05-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 021540
application number: NDA021540

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-6731-1EA - Each59762-67313b5a68d9-ee4b-4b16-82da-c857035da7cc12014-05-02
59762-6731-5EA - Each59762-67318e2efaf4-4261-47f6-a76b-d4fac5d3007312014-05-02
59762-6731-7EA - Each59762-6731f3050bf9-94db-4b1f-af88-a005c2b020ae12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
ATORVASTATIN CALCIUM TRIHYDRATEACTIVE INGREDIENT48A5M73Z4QAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
ATORVASTATINACTIVE MOIETYA0JWA85V8FAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
TALCINACTIVE INGREDIENT7SEV7J4R1UAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10
WATERINACTIVE INGREDIENT059QF0KO0RAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-6731-15976267310130 TABLET, FILM COATED in 1 BOTTLE (59762-6731-1) 2014-04-040000-00-00NoNoCurrent