Home NDC 0378-1430 Nicardipine Hydrochloride
Product NDC 0378-1430
11-digit product format 003781430
Labeler code 0378
Product ID 0378-1430_f485be32-7e98-4046-a125-b5453c3c2c74
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nicardipine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA074642
Marketing category ANDA
Marketing start 1996-07-19
Marketing end 2030-01-31
Substance NICARDIPINE HYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A074642-001 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 A074642-002 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18
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 · 86 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 2026-09-14 22:38:34 2026-08 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL 1996-07-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL 1996-07-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074642-001 NICARDIPINE HYDROCHLORIDE 20MG CAPSULE / ORAL AB 1996-07-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074642-002 NICARDIPINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1996-07-18 74a2ff9319b5…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# 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 0378-1430-05 00378143005 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1430-05) 500 capsule 1996-07-19 0000-00-00 No No Current 0378-1430-77 00378143077 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-1430-77) 90 capsule 1996-07-19 0000-00-00 No No Current