FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
62980-507
11-digit product format
629800507
Labeler code
62980
Product ID
62980-507_47f12917-32b3-4c67-95eb-29568f509556
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL; ORAL; ORAL; ORAL; ORAL
Labeler
Vivimed Labs Limited
Application
ANDA077516
Marketing category
ANDA
Marketing start
2015-04-01
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62980-507DDiscontinued by firm2026-07-31
excluded packagepackage62980-50762980-507-01DDiscontinued by firm2026-07-31
excluded packagepackage62980-50762980-507-02DDiscontinued by firm2026-07-31
excluded packagepackage62980-50762980-507-03DDiscontinued by firm2026-07-31
excluded packagepackage62980-50762980-507-04DDiscontinued 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
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