Home NDC 0054-0102 Amlodipine Besylate
Product NDC 0054-0102
11-digit product format 000540102
Labeler code 0054
Product ID 0054-0102_236a1b97-e056-4b91-b263-c53e95275adf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine Besylate
Dosage form TABLET
Route ORAL
Labeler West-Ward Pharmaceuticals Corp.
Application ANDA077262
Marketing category ANDA
Marketing start 2007-07-09
Marketing end 2020-08-20
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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077262-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 A077262-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 A077262-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077262-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077262-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077262-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-09 1e350fbaab3a…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC] 9 AMLODIPINE ACTIVE MOIETY 1J444QC288 AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC] 9 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC] 9 AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 AMLODIPINE ACTIVE MOIETY 1J444QC288 AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed RxNorm Mappings#