Home NDC 68180-765-06 Amlodipine and Valsartan
Product NDC 68180-765
Requested package NDC 68180-765-06
11-digit product format 681800765
Labeler code 68180
Product ID 68180-765_e0777a79-35ef-4f69-b6ac-94d31f7ca6fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine and Valsartan
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA090245
Marketing category ANDA
Marketing start 2015-03-31
Substance AMLODIPINE BESYLATE; VALSARTAN
Active strength 10; 160 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A090245-001 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 A090245-002 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 A090245-003 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 A090245-004 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30
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 A090245-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090245-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090245-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090245-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090245-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090245-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090245-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090245-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090245-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090245-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090245-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090245-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090245-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090245-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090245-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090245-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090245-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090245-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090245-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090245-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090245-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090245-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090245-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090245-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090245-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090245-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090245-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090245-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090245-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090245-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090245-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090245-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090245-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090245-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090245-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090245-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090245-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090245-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090245-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090245-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Amlodipine and Valsartan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 10 mg/1 VALSARTAN 160 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864V2Q084H Internal UNII lookup 80M03YXJ7I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 722126 Internal RxNorm lookup 722131 Internal RxNorm lookup 722134 Internal RxNorm lookup 722137 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-765-02 Amlodipine and Valsartan 500 in 1 BOTTLE TABLET 500 14 68180-765-06 Amlodipine and Valsartan 30 in 1 BOTTLE TABLET 30 14 68180-765-09 Amlodipine and Valsartan 90 in 1 BOTTLE TABLET 90 14 68180-765-11 Amlodipine and Valsartan 10 in 1 BLISTER PACK TABLET 10 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-765 AMLODIPINE AND VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 14 Current NDC, Legacy NDC, 4 package rows 20231215_35086164-bf92-4b3c-9845-f8cd7464c7d6.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-765-06 68180076506 30 TABLET in 1 BOTTLE (68180-765-06) 30 tablet 2015-03-31 0000-00-00 No No Current