Home NDC 70069-875 Nicardipine Hydrochloride
Product NDC 70069-875
11-digit product format 700690875
Labeler code 70069
Product ID 70069-875_035cb7ef-c5d5-4752-8d43-61b8e8420330
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nicardipine Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Somerset Therapeutics, LLC
Application ANDA220243
Marketing category ANDA
Marketing start 2026-04-20
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 2027-12-31
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 A220243-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 A220243-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22
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 2026-02-19 14:30 UTC 2026-02 A220243-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A220243-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A220243-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A220243-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220243-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220243-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
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 .1 mg/mL
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 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 70069-875-01 Nicardipine Hydrochloride 200 mL in 1 BAG INJECTION 200 2 70069-875-01 Nicardipine Hydrochloride 1 in 1 POUCH INJECTION 1 2 70069-875-10 Nicardipine Hydrochloride 10 in 1 CASE INJECTION 10 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70069-875-01 70069087501 200 mL in 1 BAG 200 ml Historical 70069-875-10 70069087510 10 POUCH in 1 CASE (70069-875-10) / 1 BAG in 1 POUCH (70069-875-01) / 200 mL in 1 BAG 10 pouch 2026-04-20 No No Current