FDA.reportPublic FDA data

Amlodipine and Atorvastatin

Product NDC
46708-760
11-digit product format
467080760
Labeler code
46708
Product ID
46708-760_ecab983e-6ed8-4440-b7b4-7ac4bf39b26c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Atorvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA217279
Marketing category
ANDA
Marketing start
2025-05-23
Substance
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
5; 40 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine and Atorvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
ATORVASTATIN CALCIUM TRIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H, 48A5M73Z4Q
Rxcui404011, 404013, 597967, 597971, 597974, 597977, 597980, 597984, 597987, 597990, 597993

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
46708-760-30Amlodipine and Atorvastatin30 in 1 BOTTLETABLET, FILM COATED301
46708-760-90Amlodipine and Atorvastatin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-760AMLODIPINE AND ATORVASTATIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20250528_ecab983e-6ed8-4440-b7b4-7ac4bf39b26c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597987amLODIPine besylate 10 MG / atorvastatin calcium 10 MG Oral TabletPSNecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597967amLODIPine besylate 10 MG / atorvastatin calcium 20 MG Oral TabletPSNecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597990amLODIPine besylate 10 MG / atorvastatin calcium 40 MG Oral TabletPSNecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
404013amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral TabletPSNecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597971amLODIPine besylate 2.5 MG / atorvastatin calcium 10 MG Oral TabletPSNecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597974amLODIPine besylate 2.5 MG / atorvastatin calcium 20 MG Oral TabletPSNecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597993amLODIPine besylate 2.5 MG / atorvastatin calcium 40 MG Oral TabletPSNecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597977amLODIPine besylate 5 MG / atorvastatin calcium 10 MG Oral TabletPSNecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597980amLODIPine besylate 5 MG / atorvastatin calcium 20 MG Oral TabletPSNecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597984amLODIPine besylate 5 MG / atorvastatin calcium 40 MG Oral TabletPSNecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
404011amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral TabletPSNecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597987amlodipine 10 MG / atorvastatin 10 MG Oral TabletSCDecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597967amlodipine 10 MG / atorvastatin 20 MG Oral TabletSCDecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597990amlodipine 10 MG / atorvastatin 40 MG Oral TabletSCDecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
404013amlodipine 10 MG / atorvastatin 80 MG Oral TabletSCDecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597971amlodipine 2.5 MG / atorvastatin 10 MG Oral TabletSCDecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597974amlodipine 2.5 MG / atorvastatin 20 MG Oral TabletSCDecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597993amlodipine 2.5 MG / atorvastatin 40 MG Oral TabletSCDecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597977amlodipine 5 MG / atorvastatin 10 MG Oral TabletSCDecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597980amlodipine 5 MG / atorvastatin 20 MG Oral TabletSCDecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597984amlodipine 5 MG / atorvastatin 40 MG Oral TabletSCDecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
404011amlodipine 5 MG / atorvastatin 80 MG Oral TabletSCDecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597987amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597967amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597990amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
404013amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597971amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597974amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597993amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597977amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597980amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
597984amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYecab983e-6ed8-4440-b7b4-7ac4bf39b26c1
404011amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYecab983e-6ed8-4440-b7b4-7ac4bf39b26c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-760-304670807603030 TABLET, FILM COATED in 1 BOTTLE (46708-760-30) 2025-05-23NoNoCurrent
46708-760-904670807609090 TABLET, FILM COATED in 1 BOTTLE (46708-760-90) 2025-05-23NoNoCurrent