FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
51079-452
11-digit product format
510790452
Labeler code
51079
Product ID
51079-452_7b2018ec-84d3-6b95-e053-2a91aa0a2626
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA076418
Marketing category
ANDA
Marketing start
2007-04-02
Marketing end
2020-07-31
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51079-452DDiscontinued by firm2026-07-31
excluded packagepackage51079-45251079-452-20DDiscontinued by firm2026-07-31
excluded packagepackage51079-45251079-452-56DDiscontinued by firm2026-07-31

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
A076418-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03
A076418-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03
A076418-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03

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 22:54:322026-06A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03a50c72e98297…
2026-08-01 22:54:322026-06A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03a50c72e98297…
2026-08-01 22:54:322026-06A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-452-01EA - Each51079-45241309d6f-ecac-4188-9a0b-292437d6585212012-07-24
51079-452-17EA - Each51079-452f91c9bd4-a565-4d28-9007-bbced77610a012012-07-24
51079-452-19EA - Each51079-45292bf8d88-0fe9-4081-a811-6dd03f67de1712012-07-24
51079-452-20EA - Each51079-452b70bed6f-6d09-480d-b127-72c397e7b7d912012-07-24
51079-452-30EA - Each51079-45278e19e5b-349f-4aea-a11f-15b1ffd818b812012-07-24
51079-452-56EA - Each51079-452f2ba9561-6711-4709-bffd-102b7088254612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8