Home NDC 50090-2471 AMLODIPINE AND VALSARTAN
Product NDC 50090-2471
11-digit product format 500902471
Labeler code 50090
Product ID 50090-2471_969dcb18-f88d-404d-bf71-79f2ec444372
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate and valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application NDA021990
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-03-30
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE; VALSARTAN
Active strength 10 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 2020-12-31
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 · 30 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 50090-2471-0 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 50090-2471-0 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 50090-2471-0 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 50090-2471-0 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 50090-2471-0 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 50090-2471-0 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 50090-2471-0 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 50090-2471-0 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 50090-2471-0 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 50090-2471-0 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 50090-2471-0 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 50090-2471-0 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-2471-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-2471-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-2471-0 1332a3947898…d4bfe170f9cd…
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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-2471-0 AMLODIPINE AND VALSARTAN 30 in 1 BOTTLE TABLET, FILM COATED 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2471 AMLODIPINE AND VALSARTAN (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 5 Legacy NDC, 1 package rows 20190225_356d67da-e879-4409-b8e5-fd06d78d361e.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 · 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-2471-0 50090247100 30 TABLET, FILM COATED in 1 BOTTLE (50090-2471-0) 2016-09-22 0000-00-00 No No Current