Home NDC 69238-2692 Nicardipine hydrochloride
Product NDC 69238-2692
11-digit product format 692382692
Labeler code 69238
Product ID 69238-2692_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 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 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 2026-02-19 14:30 UTC 2026-02 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 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…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218202-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2024-04-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218202-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-04-10 a50c72e98297…
Observed Orange Book normalized TE history# 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 69238-2692-1 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 69238-2692 NICARDIPINE HYDROCHLORIDE (NICARDIPINE) CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] 1 Current NDC, 1 package rows 20241004_79304b0f-53d3-4065-8c81-7031d1141694.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 Units Marketing start Sample Exclude flag Status 69238-2692-1 69238269201 90 CAPSULE in 1 BOTTLE (69238-2692-1) 90 capsule 2024-10-03 No No Current