FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
51655-044
11-digit product format
516550044
Labeler code
51655
Product ID
51655-044_499b91fb-79d3-b1af-e063-6294a90a3344
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
2023-11-30
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
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
ndc (product): 51655-044
AMLODIPINE BESYLATEAMLODIPINE BESYLATENorthwind Health Company, LLC03fe9ad2-3a1a-78db-e063-6294a90a2ed32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
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 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c5784b9-5542-144f-e063-6394a90a7ebcAvailable 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
51655-044-52AMLODIPINE BESYLATE30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-044AMLODIPINE BESYLATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20240127_0c5784b9-5542-144f-e063-6394a90a7ebc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197361amLODIPine besylate 5 MG Oral TabletPSN0c5784b9-5542-144f-e063-6394a90a7ebc2
197361amlodipine 5 MG Oral TabletSCD0c5784b9-5542-144f-e063-6394a90a7ebc2
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY0c5784b9-5542-144f-e063-6394a90a7ebc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-044-525165500445230 TABLET in 1 BOTTLE, PLASTIC (51655-044-52) 30 tablet2023-11-30NoNoCurrent