Home NDC 33342-280 amlodipine and valsartan
Product NDC 33342-280
11-digit product format 333420280
Labeler code 33342
Product ID 33342-280_d520c66f-440c-4f7e-b057-0d548c3142e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine and valsartan
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA207292
Marketing category ANDA
Marketing start 2024-10-16
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 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 A207292-001 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2024-10-11 A207292-002 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2024-10-11 A207292-003 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2024-10-11 A207292-004 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2024-10-11
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 2 · 44 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 A207292-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2024-10-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207292-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2024-10-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207292-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2024-10-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207292-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2024-10-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207292-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2024-10-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207292-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2024-10-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207292-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2024-10-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207292-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2024-10-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207292-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2024-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207292-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2024-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207292-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2024-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207292-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2024-10-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207292-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2024-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207292-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2024-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207292-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2024-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207292-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2024-10-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207292-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2024-10-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207292-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2024-10-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207292-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2024-10-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207292-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2024-10-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207292-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2024-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207292-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2024-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207292-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2024-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207292-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2024-10-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207292-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2024-10-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207292-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2024-10-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207292-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2024-10-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207292-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2024-10-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207292-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2024-10-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207292-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2024-10-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207292-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2024-10-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207292-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2024-10-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207292-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2024-10-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207292-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2024-10-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207292-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2024-10-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207292-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2024-10-11 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207292-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2024-10-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207292-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2024-10-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207292-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2024-10-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207292-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2024-10-11 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 33342-280-07 amlodipine and valsartan 30 in 1 BOTTLE TABLET 30 3 33342-280-10 amlodipine and valsartan 90 in 1 BOTTLE TABLET 90 3 33342-280-12 amlodipine and valsartan 10 in 1 CARTON TABLET 10 3 33342-280-12 amlodipine and valsartan 10 in 1 BLISTER PACK TABLET 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-280 AMLODIPINE AND VALSARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED] 2 Current NDC, 4 package rows 20250110_5dfadaf0-c333-4b79-9a97-e42f77505c40.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 Sample Exclude flag Status 33342-280-07 33342028007 30 TABLET in 1 BOTTLE (33342-280-07) 30 tablet 2024-10-16 No No Current 33342-280-10 33342028010 90 TABLET in 1 BOTTLE (33342-280-10) 90 tablet 2024-10-16 No No Current 33342-280-12 33342028012 10 BLISTER PACK in 1 CARTON (33342-280-12) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2024-10-16 No No Current