Home NDC 69452-437 Nicardipine Hydrochloride
Product NDC 69452-437
11-digit product format 694520437
Labeler code 69452
Product ID 69452-437_261ba7ea-d55b-1ba9-e063-6394a90a4c8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nicardipine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Bionpharma Inc.
Application ANDA217555
Marketing category ANDA
Marketing start 2024-11-04
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 A217555-001 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 A217555-002 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03
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.
Product history page 1 of 2 · 44 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 2026-02-19 14:30 UTC 2026-02 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217555-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2023-05-03 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217555-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2023-05-03 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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 69452-437-19 Nicardipine Hydrochloride 90 in 1 BOTTLE, PLASTIC CAPSULE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-437 NICARDIPINE HYDROCHLORIDE CAPSULE [BIONPHARMA INC.] 2 Current NDC, 1 package rows 20241105_7bed5d8c-30c2-4598-acf3-2edba825a56d.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 69452-437-19 69452043719 90 CAPSULE in 1 BOTTLE, PLASTIC (69452-437-19) 90 capsule 2024-11-04 No No Current