Katerzia

Product NDC: 52652-5001
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 42.

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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211340-001	10894039	2037-10-06	U-185		2021-02-16
N211340-001	10894039	2037-10-06	U-3		2021-02-16
N211340-001	10952998	2037-10-06		Drug product	2021-03-29
N211340-001	10959991	2037-10-06	U-158		2021-04-15
N211340-001	10959991	2037-10-06	U-39		2021-04-15
N211340-001	11364230	2037-10-06		Drug product	2022-06-24
N211340-001	11471409	2037-10-06	U-3447		2022-10-18
N211340-001	11471409	2037-10-06	U-3448		2022-10-18
N211340-001	11484498	2037-10-06		Drug product	2022-11-04
N211340-001	11701326	2037-10-06		Drug product	2023-07-20
N211340-001	11918685	2037-10-06	U-3447		2024-03-14
N211340-001	11918685	2037-10-06	U-3448		2024-03-14
N211340-001	12053461	2037-10-06		Drug product	2024-08-15
N211340-001	12336984	2037-10-06	U-3447		2025-06-27
N211340-001	12336984	2037-10-06	U-3448		2025-06-27
N211340-001	12383498	2037-10-06		Drug product	2025-10-29
N211340-001	10695329	2037-10-16		Drug product	2020-07-22
N211340-001	10799453	2039-04-11		Drug product	2020-11-02

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211340-001	KATERZIA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2019-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211340-001	KATERZIA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2019-07-08	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 434 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211340-001	10894039	2037-10-06	U-3		2021-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	10894039	2037-10-06	U-185		2021-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	10952998	2037-10-06		Drug product	2021-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	10959991	2037-10-06	U-39		2021-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	10959991	2037-10-06	U-158		2021-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	11364230	2037-10-06		Drug product	2022-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	11471409	2037-10-06	U-3447		2022-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	11471409	2037-10-06	U-3448		2022-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	11484498	2037-10-06		Drug product	2022-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	11701326	2037-10-06		Drug product	2023-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	11918685	2037-10-06	U-3447		2024-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	11918685	2037-10-06	U-3448		2024-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	12053461	2037-10-06		Drug product	2024-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	12336984	2037-10-06	U-3447		2025-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	12336984	2037-10-06	U-3448		2025-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	12383498	2037-10-06		Drug product	2025-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	10695329	2037-10-16		Drug product	2020-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	10799453	2039-04-11		Drug product	2020-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211340-001	10894039	2037-10-06	U-3		2021-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	10894039	2037-10-06	U-185		2021-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	10952998	2037-10-06		Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	10959991	2037-10-06	U-39		2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	10959991	2037-10-06	U-158		2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	11364230	2037-10-06		Drug product	2022-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	11471409	2037-10-06	U-3447		2022-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	11471409	2037-10-06	U-3448		2022-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	11484498	2037-10-06		Drug product	2022-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	11701326	2037-10-06		Drug product	2023-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	11918685	2037-10-06	U-3447		2024-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	11918685	2037-10-06	U-3448		2024-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	12053461	2037-10-06		Drug product	2024-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	12336984	2037-10-06	U-3447		2025-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	12336984	2037-10-06	U-3448		2025-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	12383498	2037-10-06		Drug product	2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	10695329	2037-10-16		Drug product	2020-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211340-001	10799453	2039-04-11		Drug product	2020-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211340-001	10894039	2037-10-06	U-3		2021-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211340-001	10894039	2037-10-06	U-185		2021-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211340-001	10952998	2037-10-06		Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211340-001	10959991	2037-10-06	U-39		2021-04-15	`31067a03dcf5…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
df673a4d-acb8-444c-a472-c87ab8cbd366	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
18600d07-613d-bf9c-2711-fe40c06f3393	Product name	5	20180703
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52652-5001-1	ML - Milliliter	52652-5001	3f707fe7-74e3-4a25-bde4-5a7f4e0e21b3	1	2019-08-06

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

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Katerzia	AMLODIPINE	Azurity Pharmaceuticals, Inc.	df673a4d-acb8-444c-a472-c87ab8cbd366	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211340 application number: NDA211340 ndc (product): 52652-5001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1J444QC288	AMLODIPINE	88150-42-9	Amlodipine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2184120	amLODIPine 1 MG/mL Oral Suspension	PSN	df673a4d-acb8-444c-a472-c87ab8cbd366	7
2184126	Katerzia 1 MG/mL Oral Suspension	PSN	df673a4d-acb8-444c-a472-c87ab8cbd366	7
2184126	amlodipine 1 MG/ML Oral Suspension [Katerzia]	SBD	df673a4d-acb8-444c-a472-c87ab8cbd366	7
2184120	amlodipine 1 MG/ML Oral Suspension	SCD	df673a4d-acb8-444c-a472-c87ab8cbd366	7
2184120	amlodipine 1 MG/ML (as amlodipine benzoate 1.3 MG/ML) Oral Suspension	SY	df673a4d-acb8-444c-a472-c87ab8cbd366	7
2184126	Katerzia 1 MG/ML Oral Suspension	SY	df673a4d-acb8-444c-a472-c87ab8cbd366	7

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