FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
67544-979
11-digit product format
675440979
Labeler code
67544
Product ID
67544-979_a2dfcc60-93ad-4523-aa81-fd2e2ed3a954
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076418
Marketing category
ANDA
Marketing start
2005-10-03
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
2020-12-31
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 productproduct67544-979DDiscontinued by firm2026-07-31
excluded packagepackage67544-97967544-979-15DDiscontinued by firm2026-07-31
excluded packagepackage67544-97967544-979-30DDiscontinued by firm2026-07-31
excluded packagepackage67544-97967544-979-45DDiscontinued by firm2026-07-31
excluded packagepackage67544-97967544-979-60DDiscontinued 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
67544-979-30EA - Each67544-97942201f9f-0573-4d57-8499-5b3fb3ce855e12017-12-14
67544-979-45EA - Each67544-979895be0c8-3906-412d-899a-f15a1e382e9512017-12-14