Home NDC 68462-121 Nicardipine Hydrochloride
Product NDC 68462-121
11-digit product format 684620121
Labeler code 68462
Product ID 68462-121_eb131915-222b-49d9-8e66-cd0f0afd066c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nicardipine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA216357
Marketing category ANDA
Marketing start 2022-12-16
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 2027-12-31
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 A216357-001 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 A216357-002 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16
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 · 50 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 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216357-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 2022-12-16 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216357-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2022-12-16 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nicardipine Hydrochloride
Listing expiration 2027-12-31 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 68462-121-05 Nicardipine Hydrochloride 500 in 1 BOTTLE CAPSULE 500 3 68462-121-90 Nicardipine Hydrochloride 90 in 1 BOTTLE CAPSULE 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-121 NICARDIPINE HYDROCHLORIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] 2 Current NDC, Legacy NDC, 2 package rows 20240104_3955d43d-a87f-4d2c-b90e-3ecf0d6aa148.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 Marketing end Sample Exclude flag Status 68462-121-05 68462012105 500 CAPSULE in 1 BOTTLE (68462-121-05) 500 capsule 2022-12-16 0000-00-00 No No Current 68462-121-90 68462012190 90 CAPSULE in 1 BOTTLE (68462-121-90) 90 capsule 2022-12-16 0000-00-00 No No Current