Home NDC 58151-354 Norvasc
Product NDC 58151-354
11-digit product format 581510354
Labeler code 58151
Product ID 58151-354_643fa1a0-53d9-4ce8-bc04-44285b006997
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate
Dosage form TABLET
Route ORAL
Labeler Viatris Specialty LLC
Application NDA019787
Marketing category NDA
Marketing start 2024-09-24
Substance AMLODIPINE BESYLATE
Active strength 5 mg/1
Pharmacologic classes 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 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019787-001 NORVASC AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB RLD 1992-07-31 N019787-002 NORVASC AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB RLD 1992-07-31 N019787-003 NORVASC AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB RLD, RS 1992-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
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 2026-08-01 22:54:32 2026-06 N019787-001 NORVASC EQ 2.5MG BASE TABLET / ORAL AB RLD 1992-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N019787-002 NORVASC EQ 5MG BASE TABLET / ORAL AB RLD 1992-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N019787-003 NORVASC EQ 10MG BASE TABLET / ORAL AB RLD, RS 1992-07-31 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Norvasc
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864V2Q084H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197361 Internal RxNorm lookup 212542 Internal RxNorm lookup 212549 Internal RxNorm lookup 212575 Internal RxNorm lookup 308135 Internal RxNorm lookup 308136 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 58151-354-30 Norvasc 300 in 1 BOTTLE TABLET 300 10 58151-354-77 Norvasc 90 in 1 BOTTLE TABLET 90 10 58151-354-88 Norvasc 1 in 1 BLISTER PACK TABLET 1 10 58151-354-88 Norvasc 100 in 1 BOX, UNIT-DOSE TABLET 100 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58151-354 NORVASC (AMLODIPINE BESYLATE) TABLET [VIATRIS SPECIALTY LLC] 8 Current NDC, 4 package rows 20250125_7367289c-b0b0-466a-83e2-558e2985c29f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58151-354-30 58151035430 300 TABLET in 1 BOTTLE (58151-354-30) 300 tablet 2025-01-23 No No Current 58151-354-77 58151035477 90 TABLET in 1 BOTTLE (58151-354-77) 90 tablet 2024-12-31 No No Current 58151-354-88 58151035488 100 BLISTER PACK in 1 BOX, UNIT-DOSE (58151-354-88) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2024-09-24 No No Current