Home NDC 69238-2691 Nicardipine hydrochloride
Product NDC 69238-2691
11-digit product format 692382691
Labeler code 69238
Product ID 69238-2691_8f57d96f-7e5b-409f-9e21-c3ed67369716
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nicardipine
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA218202
Marketing category ANDA
Marketing start 2024-10-03
Substance NICARDIPINE HYDROCHLORIDE
Active strength 20 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 A218202-001 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 A218202-002 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 d8e5a09893c0…2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 8072bd15b7f6…2026-08-01 22:54:32 2026-06 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 a50c72e98297…2026-08-01 22:54:32 2026-06 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 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 20 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 69238-2691-1 Nicardipine hydrochloride 90 in 1 BOTTLE CAPSULE 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-2691 NICARDIPINE HYDROCHLORIDE (NICARDIPINE) CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] 1 Current NDC, 1 package rows 20241004_79304b0f-53d3-4065-8c81-7031d1141694.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 69238-2691-1 69238269101 90 CAPSULE in 1 BOTTLE (69238-2691-1) 90 capsule 2024-10-03 No No Current