FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
0480-7167
11-digit product format
004807167
Labeler code
0480
Product ID
0480-7167_2e80607e-f2c3-4966-b360-4b39d3d1dfd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA076846
Marketing category
ANDA
Marketing start
2022-10-01
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0480-71670480-7167-98DDiscontinued 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
A076846-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-06-28
A076846-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-06-28
A076846-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076846-001AB
A076846-002AB
A076846-003AB

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 22:54:322026-06A076846-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-06-28a50c72e98297…
2026-08-01 22:54:322026-06A076846-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-06-28a50c72e98297…
2026-08-01 22:54:322026-06A076846-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-06-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076846-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A076846-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A076846-003AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATEAvKAREfeb9438a-9cbc-4855-e053-6394a90af15e2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076846
application number: ANDA076846
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC3ce6978a-6ab3-33a9-e063-6294a90a24a12025-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076846
application number: ANDA076846
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC313fe7ba-2fbd-bb4d-e063-6294a90a37492025-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076846
application number: ANDA076846
Amlodipine BesylateAMLODIPINE BESYLATETeva Pharmaceuticals, Inc.47edc328-2444-4ca1-a5c1-7c83141e105c2024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076846
application number: ANDA076846
ndc (product): 0480-7167
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCd830173d-7676-4490-ab3d-d3515df9ad2e2023-09-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076846
application number: ANDA076846

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864V2Q084HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197361Internal RxNorm lookup
308135Internal RxNorm lookup
308136Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
47edc328-2444-4ca1-a5c1-7c83141e105cAvailable on FDA.report

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
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
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
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-7167-10Amlodipine Besylate1000 in 1 BOTTLETABLET10007
0480-7167-98Amlodipine Besylate90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-7167-10EA - Each0480-7167b91432d9-8e8e-46cf-8f44-f234f8d748f012023-06-06
0480-7167-98EA - Each0480-716725e82a4b-12de-4d7c-ad75-87625687815e12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-7167AMLODIPINE BESYLATE TABLET [TEVA PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20240517_47edc328-2444-4ca1-a5c1-7c83141e105c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN47edc328-2444-4ca1-a5c1-7c83141e105c7
308136amLODIPine besylate 2.5 MG Oral TabletPSN47edc328-2444-4ca1-a5c1-7c83141e105c7
197361amLODIPine besylate 5 MG Oral TabletPSN47edc328-2444-4ca1-a5c1-7c83141e105c7
308135amlodipine 10 MG Oral TabletSCD47edc328-2444-4ca1-a5c1-7c83141e105c7
308136amlodipine 2.5 MG Oral TabletSCD47edc328-2444-4ca1-a5c1-7c83141e105c7
197361amlodipine 5 MG Oral TabletSCD47edc328-2444-4ca1-a5c1-7c83141e105c7
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY47edc328-2444-4ca1-a5c1-7c83141e105c7
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY47edc328-2444-4ca1-a5c1-7c83141e105c7
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY47edc328-2444-4ca1-a5c1-7c83141e105c7
308135amLODIPine besylate 10 MG Oral TabletPSNfeb9438a-9cbc-4855-e053-6394a90af15e2
308136amLODIPine besylate 2.5 MG Oral TabletPSNfeb9438a-9cbc-4855-e053-6394a90af15e2
197361amLODIPine besylate 5 MG Oral TabletPSNfeb9438a-9cbc-4855-e053-6394a90af15e2
308135amlodipine 10 MG Oral TabletSCDfeb9438a-9cbc-4855-e053-6394a90af15e2
308136amlodipine 2.5 MG Oral TabletSCDfeb9438a-9cbc-4855-e053-6394a90af15e2
197361amlodipine 5 MG Oral TabletSCDfeb9438a-9cbc-4855-e053-6394a90af15e2
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYfeb9438a-9cbc-4855-e053-6394a90af15e2
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYfeb9438a-9cbc-4855-e053-6394a90af15e2
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYfeb9438a-9cbc-4855-e053-6394a90af15e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0480-7167-10004807167101000 TABLET in 1 BOTTLE (0480-7167-10) 1000 tablet2023-05-11NoNoCurrent
0480-7167-980048071679890 TABLET in 1 BOTTLE (0480-7167-98) 90 tablet2022-10-010000-00-00NoNoCurrent