Home NDC 52652-5001-1 Katerzia
Product NDC 52652-5001
Requested package NDC 52652-5001-1
11-digit product format 526525001
Labeler code 52652
Product ID 52652-5001_461e8d10-1805-e107-e063-6294a90aa288
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine
Dosage form SUSPENSION
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application NDA211340
Marketing category NDA
Marketing start 2019-08-15
Substance AMLODIPINE BENZOATE
Active strength 1 mg/mL
Pharmacologic classes Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A 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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211340-001 KATERZIA AMLODIPINE BENZOATE EQ 1MG BASE/ML SUSPENSION / ORAL RLD, RS 2019-07-08
Orange Book patents# Current patent rows page 1 of 1 · 18 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 2026-08-01 22:54:32 2026-06 N211340-001 KATERZIA EQ 1MG BASE/ML SUSPENSION / ORAL RLD, RS 2019-07-08 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N211340-001 10894039 2037-10-06 U-3 2021-02-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 10894039 2037-10-06 U-185 2021-02-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 10952998 2037-10-06 Drug product 2021-03-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 10959991 2037-10-06 U-39 2021-04-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 10959991 2037-10-06 U-158 2021-04-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 11364230 2037-10-06 Drug product 2022-06-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 11471409 2037-10-06 U-3447 2022-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 11471409 2037-10-06 U-3448 2022-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 11484498 2037-10-06 Drug product 2022-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 11701326 2037-10-06 Drug product 2023-07-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 11918685 2037-10-06 U-3447 2024-03-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 11918685 2037-10-06 U-3448 2024-03-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 12053461 2037-10-06 Drug product 2024-08-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 12336984 2037-10-06 U-3447 2025-06-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 12336984 2037-10-06 U-3448 2025-06-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 12383498 2037-10-06 Drug product 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 10695329 2037-10-16 Drug product 2020-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N211340-001 10799453 2039-04-11 Drug product 2020-11-02 a50c72e98297…
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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Katerzia
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BENZOATE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XD75TQ8A2P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2184120 Internal RxNorm lookup 2184126 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 52652-5001-1 Katerzia 150 mL in 1 BOTTLE SUSPENSION 150 7 52652-5001-1 Katerzia 1 in 1 CARTON SUSPENSION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52652-5001 KATERZIA (AMLODIPINE) SUSPENSION [AZURITY PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20230719_df673a4d-acb8-444c-a472-c87ab8cbd366.zip
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 52652-5001-1 52652500101 1 BOTTLE in 1 CARTON (52652-5001-1) / 150 mL in 1 BOTTLE 1 bottle 2019-08-15 0000-00-00 No No Current