Home NDC 0378-1722 AMLODIPINE AND VALSARTAN
Product NDC 0378-1722
11-digit product format 003781722
Labeler code 0378
Product ID 0378-1722_97bfe7c1-7e4b-45a1-b045-ff48275f1488
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMLODIPINE AND VALSARTAN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA090483
Marketing category ANDA
Marketing start 2015-03-30
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A090483-001 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 A090483-002 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 A090483-003 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 A090483-004 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30
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 · 176 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 2026-10-15 13:18:30 2026-09 A090483-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090483-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090483-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090483-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090483-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090483-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090483-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090483-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090483-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090483-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090483-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090483-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090483-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090483-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090483-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090483-004 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 A090483-001 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 A090483-002 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 A090483-003 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 A090483-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090483-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090483-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090483-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090483-004 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 A090483-001 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 A090483-002 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 A090483-003 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 A090483-004 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 A090483-001 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 A090483-002 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 A090483-003 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 A090483-004 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 A090483-001 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 A090483-002 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 A090483-003 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 A090483-004 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 A090483-001 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 A090483-002 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 A090483-003 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 A090483-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 5 · 176 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 2027-12-31 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 80M03YXJ7I Internal UNII lookup 864V2Q084H 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 0378-1722-93 AMLODIPINE AND VALSARTAN 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 AMLODIPINE ACTIVE MOIETY 1J444QC288 AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 VALSARTAN ACTIVE MOIETY 80M03YXJ7I AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 SODIUM STARCH GLYCOLATE TYPE B POTATO INACTIVE INGREDIENT 27NA468985 AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-1722 AMLODIPINE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 Current NDC, Legacy NDC, 1 package rows 20240712_aa7e7d95-520a-461c-b1b3-e588aeb6a613.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 Marketing start Marketing end Sample Exclude flag Status 0378-1722-93 00378172293 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1722-93) 2015-03-30 0000-00-00 No No Current