Home NDC 70710-2011 Nicardipine Hydrochloride
Product NDC 70710-2011
11-digit product format 707102011
Labeler code 70710
Product ID 70710-2011_bf108728-380c-41b5-a730-1ddd2c0051ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nicardipine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA218638
Marketing category ANDA
Marketing start 2025-08-01
Substance NICARDIPINE HYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218638-001 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 2025-06-25 A218638-002 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2025-06-25
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 2026-02-19 14:30 UTC 2026-02 A218638-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2025-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218638-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2025-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218638-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2025-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218638-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2025-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218638-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2025-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218638-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2025-06-25 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218638-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 2025-06-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218638-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 2025-06-25 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nicardipine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICARDIPINE HYDROCHLORIDE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K5BC5011K3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858613 Internal RxNorm lookup 858616 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 70710-2011-9 Nicardipine Hydrochloride 90 in 1 BOTTLE CAPSULE 90 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70710-2011-9 70710201109 90 CAPSULE in 1 BOTTLE (70710-2011-9) 90 capsule 2025-08-01 No No Current