FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
72789-261
11-digit product format
727890261
Labeler code
72789
Product ID
72789-261_41d6707a-c54e-5987-e063-6294a90ab185
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078414
Marketing category
ANDA
Marketing start
2021-10-01
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

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
A078414-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-07
A078414-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-07
A078414-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078414-001AB
A078414-002AB
A078414-003AB

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 22:54:322026-06A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-07a50c72e98297…
2026-08-01 22:54:322026-06A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-07a50c72e98297…
2026-08-01 22:54:322026-06A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078414-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078414-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078414-003AB1a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.1080fcea-a5da-499d-a855-690c135590712026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
ndc (product): 72789-261
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEOxford Pharmaceuticals, LLC6f20efca-943b-4bc2-a157-0931bd4d45852026-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.ea9f44a1-96cf-496a-8c07-18d8de27e5122026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC49104797-8202-1376-e063-6294a90adb382026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC47e494d2-8971-3f8f-e063-6394a90adb202026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEProficient Rx LP6313edc5-d2d5-44a1-a06f-7f7829c870d22025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC1871ddaf-ed2c-c3ce-e063-6394a90a1bee2024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.ffe96aa1-db66-33e4-e053-6394a90a7e4e2024-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC132c078d-7d31-a6f2-e063-6294a90af0952024-03-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCb597d1e1-aba1-4272-bed7-4c95e8150d582023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414

Additional Listing Data#

Finished product
Yes
Brand name base
AMLODIPINE BESYLATE
Brand name suffix
5 mg
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 · 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
1080fcea-a5da-499d-a855-690c13559071Available 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
72789-261-30AMLODIPINE BESYLATE5 mg30 in 1 BOTTLE, PLASTICTABLET3017
72789-261-60AMLODIPINE BESYLATE5 mg60 in 1 BOTTLE, PLASTICTABLET6017
72789-261-90AMLODIPINE BESYLATE5 mg90 in 1 BOTTLE, PLASTICTABLET9017
72789-261-95AMLODIPINE BESYLATE5 mg1000 in 1 BOTTLE, PLASTICTABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-261-30EA - Each72789-261e4b7c445-d319-4bbb-a02f-fbe8cfd1deb012023-05-05
72789-261-60EA - Each72789-261b1dfc681-c6a7-4dfe-96f5-6bcdc885dc0312023-05-05
72789-261-90EA - Each72789-261abf4eecf-5d5a-4271-93b3-fb1d85bfddd812022-08-04
72789-261-95EA - Each72789-261d3356a57-5028-455b-90ab-1f5e38d7f67e12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-261AMLODIPINE BESYLATE 5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 2.5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 4 package rows20250121_1080fcea-a5da-499d-a855-690c13559071.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN1080fcea-a5da-499d-a855-690c1355907117
308136amLODIPine besylate 2.5 MG Oral TabletPSN1080fcea-a5da-499d-a855-690c1355907117
197361amLODIPine besylate 5 MG Oral TabletPSN1080fcea-a5da-499d-a855-690c1355907117
308135amlodipine 10 MG Oral TabletSCD1080fcea-a5da-499d-a855-690c1355907117
308136amlodipine 2.5 MG Oral TabletSCD1080fcea-a5da-499d-a855-690c1355907117
197361amlodipine 5 MG Oral TabletSCD1080fcea-a5da-499d-a855-690c1355907117
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY1080fcea-a5da-499d-a855-690c1355907117
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY1080fcea-a5da-499d-a855-690c1355907117
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY1080fcea-a5da-499d-a855-690c1355907117
197361amLODIPine besylate 5 MG Oral TabletPSNb597d1e1-aba1-4272-bed7-4c95e8150d582
197361amlodipine 5 MG Oral TabletSCDb597d1e1-aba1-4272-bed7-4c95e8150d582
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYb597d1e1-aba1-4272-bed7-4c95e8150d582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-261-307278902613030 TABLET in 1 BOTTLE, PLASTIC (72789-261-30) 30 tablet2023-04-20NoNoCurrent
72789-261-607278902616060 TABLET in 1 BOTTLE, PLASTIC (72789-261-60) 60 tablet2023-04-20NoNoCurrent
72789-261-907278902619090 TABLET in 1 BOTTLE, PLASTIC (72789-261-90) 90 tablet2022-07-150000-00-00NoNoCurrent
72789-261-95727890261951000 TABLET in 1 BOTTLE, PLASTIC (72789-261-95) 1000 tablet2022-07-150000-00-00NoNoCurrent