Home DailyMed 3cb2d03c-6660-45d3-8ae2-59f0d71cbcf3 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 01:33:53 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022314-001 EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 N022314-002 EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 N022314-003 EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 N022314-004 EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 N022314-005 EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 215 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 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 observed states.
Observed Orange Book patent history# Patent history page 1 of 9 · 360 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-001 8101599 2023-05-16 Drug product 2012-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-001 8475839 2023-05-16 Drug product 2013-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-001 8475839*PED 2023-11-16 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-002 8101599 2023-05-16 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-002 8475839 2023-05-16 Drug product 2013-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-002 8475839*PED 2023-11-16 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-003 8101599 2023-05-16 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-003 8475839 2023-05-16 Drug product 2013-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-003 8475839*PED 2023-11-16 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-004 8101599 2023-05-16 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-004 8475839 2023-05-16 Drug product 2013-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-004 8475839*PED 2023-11-16 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-005 8101599 2023-05-16 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-005 8475839 2023-05-16 Drug product 2013-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-005 8475839*PED 2023-11-16 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022314-001 8101599 2023-05-16 Drug product 2012-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-001 8475839 2023-05-16 Drug product 2013-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-001 8475839*PED 2023-11-16 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-002 8101599 2023-05-16 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-002 8475839 2023-05-16 Drug product 2013-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-002 8475839*PED 2023-11-16 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-003 8101599 2023-05-16 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-003 8475839 2023-05-16 Drug product 2013-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-003 8475839*PED 2023-11-16 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-004 8101599 2023-05-16 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-004 8475839 2023-05-16 Drug product 2013-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-004 8475839*PED 2023-11-16 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-005 8101599 2023-05-16 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-005 8475839 2023-05-16 Drug product 2013-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-005 8475839*PED 2023-11-16 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022314-001 8101599 2023-05-16 Drug product 2012-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-001 8475839 2023-05-16 Drug product 2013-08-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-001 8475839*PED 2023-11-16 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-002 8101599 2023-05-16 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-002 8475839 2023-05-16 Drug product 2013-08-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-002 8475839*PED 2023-11-16 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-003 8101599 2023-05-16 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-003 8475839 2023-05-16 Drug product 2013-08-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-003 8475839*PED 2023-11-16 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-004 8101599 2023-05-16 Drug product 4b0b4de00fa7…
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 HCT AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE Novartis Pharmaceuticals Corporation 18d7820d-471f-4ee2-9ec6-25d8d27c77de 2025-12-12 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (package): 0078-0560-15 ndc11 (package): 00078056015
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.