FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
51655-869
11-digit product format
516550869
Labeler code
51655
Product ID
51655-869_4bbccd59-d18a-4b0a-e063-6294a90a5d1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077073
Marketing category
ANDA
Marketing start
2023-08-25
Substance
AMLODIPINE BESYLATE
Active strength
10 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
2027-12-31
Current FDA listing
Yes

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
A077073-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-26
A077073-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-26
A077073-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077073-001AB
A077073-002AB
A077073-003AB

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 22:54:322026-06A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-26a50c72e98297…
2026-08-01 22:54:322026-06A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-26a50c72e98297…
2026-08-01 22:54:322026-06A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077073-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077073-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077073-003AB1a50c72e98297…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATEAMLODIPINE BESYLATENuCare Pharmaceuticals, Inc.4926f00c-ee19-3e10-e054-00144ff88e882026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.d09173a1-5e3c-4c86-8c7c-15238925ef502026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb552026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch Prepackf546047f-1cc6-4bbe-a67b-b5c9815b89af2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch Prepack215e0890-0484-45e8-a731-aea53821ad8e2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
AMLODIPINE BESYLATEAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.aec7618e-c9da-431f-8b6a-14aa399242f62026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
AMLODIPINE BESYLATEAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.e01efe66-2f31-4261-92ca-0b41f27104da2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
AMLODIPINE BESYLATEAMLODIPINE BESYLATENorthwind Health Company, LLC0c5784b9-5542-144f-e063-6394a90a7ebc2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
AMLODIPINE BESYLATEAMLODIPINE BESYLATENorthwind Health Company, LLC03fe9ad2-3a1a-78db-e063-6294a90a2ed32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
ndc (product): 51655-869
AMLODIPINE BESYLATEAMLODIPINE BESYLATECipla USA Inc.5409b296-3bed-47cd-abba-9fe6f6833af62025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
AMLODIPINE BESYLATEAMLODIPINE BESYLATEQuallent Pharmaceuticals Health LLCc262dedb-1d13-4447-9355-f11e1dbbfb4d2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
AMLODIPINE BESYLATEAMLODIPINE BESYLATEProficient Rx LP410aa0a5-43cf-455c-b51d-7dfbc24eee322020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073

Additional Listing Data#

Finished product
Yes
Brand name base
AMLODIPINE BESYLATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03fe9ad2-3a1a-78db-e063-6294a90a2ed3Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-869-262026-01-29C16284748780-149896155-aa3d-586f-e063-e6dba90add90These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
51655-869-522026-01-29C16284748780-149896155-aa3d-586f-e063-e6dba90add90These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
51655-869-832026-01-29C16284748780-149896155-aa3d-586f-e063-e6dba90add90These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-869-26AMLODIPINE BESYLATE90 in 1 BOTTLE, PLASTICTABLET904
51655-869-52AMLODIPINE BESYLATE30 in 1 BOTTLE, PLASTICTABLET304
51655-869-83AMLODIPINE BESYLATE180 in 1 BOTTLE, PLASTICTABLET1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-869AMLODIPINE BESYLATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 3 package rows20240627_03fe9ad2-3a1a-78db-e063-6294a90a2ed3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN03fe9ad2-3a1a-78db-e063-6294a90a2ed34
308135amlodipine 10 MG Oral TabletSCD03fe9ad2-3a1a-78db-e063-6294a90a2ed34
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY03fe9ad2-3a1a-78db-e063-6294a90a2ed34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-869-265165508692690 TABLET in 1 BOTTLE, PLASTIC (51655-869-26) 90 tablet2024-03-25NoNoCurrent
51655-869-525165508695230 TABLET in 1 BOTTLE, PLASTIC (51655-869-52) 30 tablet2023-08-25NoNoCurrent
51655-869-8351655086983180 TABLET in 1 BOTTLE, PLASTIC (51655-869-83) 180 tablet2023-12-21NoNoCurrent