Home NDC 64380-216 Amlodipine and Valsartan
Product NDC 64380-216
11-digit product format 643800216
Labeler code 64380
Product ID 64380-216_1da81b6e-f1da-46de-8396-592cd855801b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine and valsartan
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA090011
Marketing category ANDA
Marketing start 2022-10-24
Substance AMLODIPINE; VALSARTAN
Active strength 5; 320 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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-216-01 Amlodipine and Valsartan 30 in 1 BOTTLE, PLASTIC TABLET 30 6 64380-216-02 Amlodipine and Valsartan 90 in 1 BOTTLE, PLASTIC TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-216 AMLODIPINE AND VALSARTAN TABLET [STRIDES PHARMA SCIENCE LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20241023_2094f801-4e92-47cd-9487-98f4043abd3c.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 · 2 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 64380-216-01 64380021601 30 TABLET in 1 BOTTLE, PLASTIC (64380-216-01) 30 tablet 2022-10-24 0000-00-00 No No Current 64380-216-02 64380021602 90 TABLET in 1 BOTTLE, PLASTIC (64380-216-02) 90 tablet 2022-10-24 0000-00-00 No No Current