Home NDC 0781-5615 AMLODIPINE AND VALSARTAN
Product NDC 0781-5615
11-digit product format 007815615
Labeler code 0781
Product ID 0781-5615_054546f4-f406-4a5c-91ba-d981071cf38b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate and valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application NDA021990
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-03-30
Marketing end 2022-09-30
Substance AMLODIPINE BESYLATE; VALSARTAN
Active strength 5 mg/1; mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0781-5615-31 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0781-5615-31 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0781-5615-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0781-5615-31 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0781-5615-31 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0781-5615-31 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0781-5615-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0781-5615-31 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0781-5615-31 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0781-5615-31 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0781-5615-31 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0781-5615-31 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021990-002 EXFORGE AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB RLD 2007-06-20 N021990-003 EXFORGE AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB RLD, RS 2007-06-20 N021990-004 EXFORGE AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB RLD 2007-06-20 N021990-005 EXFORGE AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB RLD, RS 2007-06-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 172 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 2026-09-14 22:38:34 2026-08 N021990-002 EXFORGE EQ 5MG BASE;160MG TABLET / ORAL AB RLD 2007-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021990-003 EXFORGE EQ 10MG BASE;160MG TABLET / ORAL AB RLD, RS 2007-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021990-004 EXFORGE EQ 5MG BASE;320MG TABLET / ORAL AB RLD 2007-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021990-005 EXFORGE EQ 10MG BASE;320MG TABLET / ORAL AB RLD, RS 2007-06-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021990-002 EXFORGE EQ 5MG BASE;160MG TABLET / ORAL AB RLD 2007-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021990-003 EXFORGE EQ 10MG BASE;160MG TABLET / ORAL AB RLD, RS 2007-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021990-004 EXFORGE EQ 5MG BASE;320MG TABLET / ORAL AB RLD 2007-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021990-005 EXFORGE EQ 10MG BASE;320MG TABLET / ORAL AB RLD, RS 2007-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021990-002 EXFORGE EQ 5MG BASE;160MG TABLET / ORAL AB RLD 2007-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021990-003 EXFORGE EQ 10MG BASE;160MG TABLET / ORAL AB RLD, RS 2007-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021990-004 EXFORGE EQ 5MG BASE;320MG TABLET / ORAL AB RLD 2007-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021990-005 EXFORGE EQ 10MG BASE;320MG TABLET / ORAL AB RLD, RS 2007-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021990-002 EXFORGE EQ 5MG BASE;160MG TABLET / ORAL AB RLD 2007-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021990-003 EXFORGE EQ 10MG BASE;160MG TABLET / ORAL AB RLD, RS 2007-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021990-004 EXFORGE EQ 5MG BASE;320MG TABLET / ORAL AB RLD 2007-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021990-005 EXFORGE EQ 10MG BASE;320MG TABLET / ORAL AB RLD, RS 2007-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021990-002 EXFORGE EQ 5MG BASE;160MG TABLET / ORAL AB RLD 2007-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021990-003 EXFORGE EQ 10MG BASE;160MG TABLET / ORAL AB RLD, RS 2007-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021990-004 EXFORGE EQ 5MG BASE;320MG TABLET / ORAL AB RLD 2007-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021990-005 EXFORGE EQ 10MG BASE;320MG TABLET / ORAL AB RLD, RS 2007-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021990-002 EXFORGE EQ 5MG BASE;160MG TABLET / ORAL AB RLD 2007-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021990-003 EXFORGE EQ 10MG BASE;160MG TABLET / ORAL AB RLD, RS 2007-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021990-004 EXFORGE EQ 5MG BASE;320MG TABLET / ORAL AB RLD 2007-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021990-005 EXFORGE EQ 10MG BASE;320MG TABLET / ORAL AB RLD, RS 2007-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021990-002 EXFORGE EQ 5MG BASE;160MG TABLET / ORAL AB RLD 2007-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021990-003 EXFORGE EQ 10MG BASE;160MG TABLET / ORAL AB RLD, RS 2007-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021990-004 EXFORGE EQ 5MG BASE;320MG TABLET / ORAL AB RLD 2007-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021990-005 EXFORGE EQ 10MG BASE;320MG TABLET / ORAL AB RLD, RS 2007-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021990-002 EXFORGE EQ 5MG BASE;160MG TABLET / ORAL AB RLD 2007-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021990-003 EXFORGE EQ 10MG BASE;160MG TABLET / ORAL AB RLD, RS 2007-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021990-004 EXFORGE EQ 5MG BASE;320MG TABLET / ORAL AB RLD 2007-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021990-005 EXFORGE EQ 10MG BASE;320MG TABLET / ORAL AB RLD, RS 2007-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021990-002 EXFORGE EQ 5MG BASE;160MG TABLET / ORAL AB RLD 2007-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021990-003 EXFORGE EQ 10MG BASE;160MG TABLET / ORAL AB RLD, RS 2007-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021990-004 EXFORGE EQ 5MG BASE;320MG TABLET / ORAL AB RLD 2007-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021990-005 EXFORGE EQ 10MG BASE;320MG TABLET / ORAL AB RLD, RS 2007-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021990-002 EXFORGE EQ 5MG BASE;160MG TABLET / ORAL AB RLD 2007-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021990-003 EXFORGE EQ 10MG BASE;160MG TABLET / ORAL AB RLD, RS 2007-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021990-004 EXFORGE EQ 5MG BASE;320MG TABLET / ORAL AB RLD 2007-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021990-005 EXFORGE EQ 10MG BASE;320MG TABLET / ORAL AB RLD, RS 2007-06-20 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Observed Orange Book patent history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 AMLODIPINE ACTIVE MOIETY 1J444QC288 AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 VALSARTAN ACTIVE MOIETY 80M03YXJ7I AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [SANDOZ INC] 1
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Exforge AMLODIPINE BESYLATE AND VALSARTAN Novartis Pharmaceuticals Corporation d0caec89-96ec-411d-a933-63eda74a6da7 2026-02-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021990 application number: NDA021990