Home NDC 42806-501 Nicardipine Hydrochloride
Product NDC 42806-501
11-digit product format 428060501
Labeler code 42806
Product ID 42806-501_cdaf4385-811f-4e33-9990-b4e2586b81b3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nicardipine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA074928
Marketing category ANDA
Marketing start 2010-05-05
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 42 .
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 A074928-001 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 A074928-002 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 1998-03-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074928-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1998-03-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074928-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1998-03-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
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 42806-501-01 Nicardipine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 10 42806-501-05 Nicardipine Hydrochloride 500 in 1 BOTTLE CAPSULE 500 10 42806-501-09 Nicardipine Hydrochloride 90 in 1 BOTTLE CAPSULE 90 10 42806-501-10 Nicardipine Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NICARDIPINE HYDROCHLORIDE ACTIVE INGREDIENT K5BC5011K3 NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6 NICARDIPINE ACTIVE MOIETY CZ5312222S NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-501 NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] 10 Current NDC, Legacy NDC, 4 package rows 20231228_b8f147b8-955f-4733-9178-2cfa0beb60d6.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42806-501-01 42806050101 100 CAPSULE in 1 BOTTLE (42806-501-01) 100 capsule 2010-05-05 0000-00-00 No No Current 42806-501-05 42806050105 500 CAPSULE in 1 BOTTLE (42806-501-05) 500 capsule 2010-05-05 0000-00-00 No No Current 42806-501-09 42806050109 90 CAPSULE in 1 BOTTLE (42806-501-09) 90 capsule 2010-05-05 0000-00-00 No No Current 42806-501-10 42806050110 1000 CAPSULE in 1 BOTTLE (42806-501-10) 1000 capsule 2010-05-05 0000-00-00 No No Current