Home NDC 69097-007 NICARDIPINE HYDROCHLORIDE
Product NDC 69097-007
11-digit product format 690970007
Labeler code 69097
Product ID 69097-007_d477e259-4e07-433c-b230-d3dd63331866
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nicardipine hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Cipla USA Inc.
Application ANDA215592
Marketing category ANDA
Marketing start 2024-10-02
Substance NICARDIPINE HYDROCHLORIDE
Active strength .1 mg/mL
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 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24
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 2026-08-18 06:07:40 2026-07 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215592-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215592-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-24 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215592-001 CGT 2025-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215592-002 CGT 2025-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215592-001 CGT 2025-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215592-002 CGT 2025-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215592-001 CGT 2025-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215592-002 CGT 2025-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215592-001 CGT 2025-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215592-002 CGT 2025-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215592-001 CGT 2025-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215592-002 CGT 2025-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215592-001 CGT 2025-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215592-002 CGT 2025-05-21 2680178bc6a6…
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 .1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K5BC5011K3 Internal UNII lookup CZ5312222S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858599 Internal RxNorm lookup 858603 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 69097-007-22 NICARDIPINE HYDROCHLORIDE 10 in 1 CARTON INJECTION 10 4 69097-007-45 NICARDIPINE HYDROCHLORIDE 200 mL in 1 BAG INJECTION 200 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-007 NICARDIPINE HYDROCHLORIDE INJECTION [CIPLA USA INC.] 3 Current NDC, 2 package rows 20241003_570af1f8-6718-4b40-ae89-0f738d330ebd.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 69097-007-22 69097000722 10 BAG in 1 CARTON (69097-007-22) / 200 mL in 1 BAG (69097-007-45) 10 bag 2024-10-02 No No Current 69097-007-45 69097000745 200 mL in 1 BAG 200 ml Historical