AMLODIPINE BESYLATE

Product NDC
63187-914
11-digit product format
631870914
Labeler code
63187
Product ID
63187-914_b9f0a743-12ea-403f-bf32-d2e003d8815b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077073
Marketing category
ANDA
Marketing start
2007-09-26
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [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 42.

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077073-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-09-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077073-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-09-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077073-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-09-261e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077073-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077073-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077073-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077073-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077073-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077073-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077073-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077073-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077073-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077073-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077073-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077073-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077073-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077073-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077073-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077073-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077073-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077073-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077073-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077073-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077073-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077073-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077073-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077073-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077073-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077073-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077073-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077073-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077073-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077073-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077073-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077073-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077073-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077073-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077073-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077073-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077073-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077073-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077073-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077073-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
AMLODIPINE BESYLATE
Listing expiration
2026-12-31

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
410aa0a5-43cf-455c-b51d-7dfbc24eee32Available 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
63187-914-30AMLODIPINE BESYLATE30 in 1 BOTTLETABLET304
63187-914-60AMLODIPINE BESYLATE60 in 1 BOTTLETABLET604
63187-914-90AMLODIPINE BESYLATE90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-914-30EA - Each63187-914ddf94550-9b0a-4910-b621-e737a29ac37812018-02-20
63187-914-90EA - Each63187-9140059b43d-24fc-4fb3-956b-4796cd4f6e4312020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-914AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20200206_410aa0a5-43cf-455c-b51d-7dfbc24eee32.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATEAMLODIPINE BESYLATERedpharm Drug58336a97-807a-2859-e063-6294a90ad3382026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077073
application number: ANDA077073
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
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
ndc (product): 63187-914

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN410aa0a5-43cf-455c-b51d-7dfbc24eee324
308135amlodipine 10 MG Oral TabletSCD410aa0a5-43cf-455c-b51d-7dfbc24eee324
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY410aa0a5-43cf-455c-b51d-7dfbc24eee324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-914-306318709143030 TABLET in 1 BOTTLE (63187-914-30) 30 tablet2017-10-020000-00-00NoNoCurrent
63187-914-606318709146060 TABLET in 1 BOTTLE (63187-914-60) 60 tablet2017-10-020000-00-00NoNoCurrent
63187-914-906318709149090 TABLET in 1 BOTTLE (63187-914-90) 90 tablet2017-10-020000-00-00NoNoCurrent