FDA.reportPublic FDA data

Caduet

Product NDC
0069-7476
11-digit product format
000697476
Labeler code
0069
Product ID
0069-7476_f7f456e3-dc8d-4266-bc71-52ea64c2f270
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine and atorvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA021540
Marketing category
NDA
Marketing start
2022-08-31
Substance
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10; 80 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1
ATORVASTATIN CALCIUM TRIHYDRATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q, 864V2Q084H
Rxcui404011, 404013, 597967, 597977, 597980, 597984, 597987, 597990, 750199, 750203, 750207, 750211, 750227, 750231, 750235, 750239

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
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
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
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-7476-30Caduet30 in 1 BOTTLETABLET, FILM COATED3051

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-7476-30EA - Each0069-747629584855-795f-4f2e-b1ad-4fc3593083ec12023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HCADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
ATORVASTATIN CALCIUM TRIHYDRATEACTIVE INGREDIENT48A5M73Z4QCADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
AMLODIPINEACTIVE MOIETY1J444QC288CADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
ATORVASTATINACTIVE MOIETYA0JWA85V8FCADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKCADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746CADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
TALCINACTIVE INGREDIENT7SEV7J4R1UCADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23
WATERINACTIVE INGREDIENT059QF0KO0RCADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-7476CADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED CADUET (AMLODIPINE AND ATORVASTATIN) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]50Current NDC, Legacy NDC, 1 package rows20250305_6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597987amLODIPine besylate 10 MG / atorvastatin calcium 10 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597967amLODIPine besylate 10 MG / atorvastatin calcium 20 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597990amLODIPine besylate 10 MG / atorvastatin calcium 40 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
404013amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597977amLODIPine besylate 5 MG / atorvastatin calcium 10 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597980amLODIPine besylate 5 MG / atorvastatin calcium 20 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597984amLODIPine besylate 5 MG / atorvastatin calcium 40 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
404011amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750199Caduet 10 MG / 10 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750203Caduet 10 MG / 20 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750207Caduet 10 MG / 40 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750211Caduet 10 MG / 80 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750227Caduet 5 MG / 10 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750231Caduet 5 MG / 20 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750235Caduet 5 MG / 40 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750239Caduet 5 MG / 80 MG Oral TabletPSN6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750199amlodipine 10 MG / atorvastatin 10 MG Oral Tablet [Caduet]SBD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750203amlodipine 10 MG / atorvastatin 20 MG Oral Tablet [Caduet]SBD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750207amlodipine 10 MG / atorvastatin 40 MG Oral Tablet [Caduet]SBD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750211amlodipine 10 MG / atorvastatin 80 MG Oral Tablet [Caduet]SBD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750227amlodipine 5 MG / atorvastatin 10 MG Oral Tablet [Caduet]SBD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750231amlodipine 5 MG / atorvastatin 20 MG Oral Tablet [Caduet]SBD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750235amlodipine 5 MG / atorvastatin 40 MG Oral Tablet [Caduet]SBD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750239amlodipine 5 MG / atorvastatin 80 MG Oral Tablet [Caduet]SBD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597987amlodipine 10 MG / atorvastatin 10 MG Oral TabletSCD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597967amlodipine 10 MG / atorvastatin 20 MG Oral TabletSCD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597990amlodipine 10 MG / atorvastatin 40 MG Oral TabletSCD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
404013amlodipine 10 MG / atorvastatin 80 MG Oral TabletSCD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597977amlodipine 5 MG / atorvastatin 10 MG Oral TabletSCD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597980amlodipine 5 MG / atorvastatin 20 MG Oral TabletSCD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597984amlodipine 5 MG / atorvastatin 40 MG Oral TabletSCD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
404011amlodipine 5 MG / atorvastatin 80 MG Oral TabletSCD6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597987amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597967amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597990amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
404013amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597977amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597980amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
597984amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
404011amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750199Caduet 10/10 MG Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750203Caduet 10/20 MG Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750207Caduet 10/40 MG Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750211Caduet 10/80 (amlodipine / atorvastatin) Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750211Caduet 10/80 Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750227Caduet 5/10 (amlodipine / atorvastatin) Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750227Caduet 5/10 Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750231Caduet 5/20 (amlodipine / atorvastatin) Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750231Caduet 5/20 Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750235Caduet 5/40 (amlodipine / atorvastatin) Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750235Caduet 5/40 Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750239Caduet 5/80 (amlodipine / atorvastatin) Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651
750239Caduet 5/80 Oral TabletSY6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-7476-300006974763030 TABLET, FILM COATED in 1 BOTTLE (0069-7476-30) 2022-08-310000-00-00NoNoCurrent