Home NDC 42291-022-30 Amlodipine and Valsartan
Product NDC 42291-022
Requested package NDC 42291-022-30
11-digit product format 422910022
Labeler code 42291
Product ID 42291-022_bf65a563-c414-66e7-e053-2a95a90aa6d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine and valsartan
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA090011
Marketing category ANDA
Marketing start 2018-09-11
Marketing end 0000-00-00
Substance AMLODIPINE; 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 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 A090011-001 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2013-03-28 A090011-002 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2013-03-28 A090011-003 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2013-03-28 A090011-004 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2013-03-28
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 A090011-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2013-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090011-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2013-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090011-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2013-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090011-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2013-03-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090011-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2013-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090011-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2013-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090011-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2013-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090011-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2013-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090011-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2013-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090011-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2013-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090011-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2013-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090011-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2013-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090011-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2013-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090011-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2013-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090011-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2013-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090011-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2013-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090011-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2013-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090011-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2013-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090011-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2013-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090011-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2013-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090011-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2013-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090011-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2013-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090011-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2013-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090011-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2013-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090011-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2013-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090011-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2013-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090011-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2013-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090011-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2013-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090011-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2013-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090011-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2013-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090011-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2013-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090011-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2013-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090011-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2013-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090011-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2013-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090011-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2013-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090011-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2013-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090011-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2013-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090011-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2013-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090011-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2013-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090011-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2013-03-28 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 136 observed states.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-022-30 42291002230 30 TABLET in 1 BOTTLE, PLASTIC (42291-022-30) 30 tablet 2018-09-11 0000-00-00 No No Current