Home DailyMed 3fcfcb93-42da-4d4d-9c42-e937a8dc44b2 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:35:24 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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# 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 ndc (package): 0078-0491-15 ndc11 (package): 00078049115
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.