Levamlodipine

Product NDC: 42195-425
Requested package NDC: 42195-425-30
11-digit product format: 421950425
Labeler code: 42195
Product ID: 42195-425_d112ff93-0fa0-1774-e053-2995a90afaef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levamlodipine
Dosage form: TABLET
Route: ORAL
Labeler: Xspire Pharma, LLC
Application: NDA212895
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2021-08-15
Marketing end: 0000-00-00
Substance: LEVAMLODIPINE MALEATE
Active strength: 3 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42195-425	42195-425-30	I	Inactivated by FDA		2026-08-03

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212895-001	CONJUPRI	LEVAMLODIPINE MALEATE	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19
N212895-002	CONJUPRI	LEVAMLODIPINE MALEATE	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19
N212895-003	CONJUPRI	LEVAMLODIPINE MALEATE	EQ 5MG BASE	TABLET / ORAL	RLD	2019-12-19

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 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD	2019-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD	2019-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD	2019-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD	2019-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD	2019-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD	2019-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD	2019-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD, RS	2019-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD	2019-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD	2019-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD, RS	2019-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD, RS	2019-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212895-002	CONJUPRI	EQ 2.5MG BASE	TABLET / ORAL	RLD	2019-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212895-003	CONJUPRI	EQ 5MG BASE	TABLET / ORAL	RLD, RS	2019-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212895-001	CONJUPRI	EQ 1.25MG BASE	TABLET / ORAL	RLD	2019-12-19	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99ce1bff-cadd-48bc-9910-990f58aed76b	Product name	1	20200604

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42195-425-30	2024-01-30	C162847	48780-1	1030e364-fe11-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use LEVAMLODIPINE TABLETS safely and effectively. See full prescribing information for LEVAMLODIPINE TABLETS. LEVAMLODIPINE TABLETS, for oral use. Initial U.S. Approval: 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42195-425-30	Levamlodipine	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42195-425-30	EA - Each	42195-425	7d079c8f-b2ac-4aa7-89b3-9e150c15785f	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42195-425	LEVAMLODIPINE TABLET [XSPIRE PHARMA, LLC]	1	Legacy NDC, 1 package rows	20211119_664ea032-2dd4-41ef-8506-c453cba57144.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
Conjupri	LEVAMLODIPINE	CSPC Ouyi Pharmaceutical Co. Ltd	c3cca66e-348a-43e8-8f96-e995104dae3d	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212895 application number: NDA212895

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
12WW9T2ITA	LEVAMLODIPINE MALEATE		LEVAMLODIPINE MALEATE
0P6NLP6806	LEVAMLODIPINE	103129-82-4	levamlodipine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2377367	levamlodipine 2.5 MG Oral Tablet	PSN	664ea032-2dd4-41ef-8506-c453cba57144	1
2377371	levamlodipine 5 MG Oral Tablet	PSN	664ea032-2dd4-41ef-8506-c453cba57144	1
2377367	levamlodipine 2.5 MG Oral Tablet	SCD	664ea032-2dd4-41ef-8506-c453cba57144	1
2377371	levamlodipine 5 MG Oral Tablet	SCD	664ea032-2dd4-41ef-8506-c453cba57144	1
2377367	levamlodipine 2.5 MG (equivalent to levamlodipine maleate 3.2 MG) Oral Tablet	SY	664ea032-2dd4-41ef-8506-c453cba57144	1
2377371	levamlodipine 5 MG (equivalent to levamlodipine maleate 6.4 MG) Oral Tablet	SY	664ea032-2dd4-41ef-8506-c453cba57144	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42195-425-30	42195042530	30 TABLET in 1 BOTTLE (42195-425-30)	30 tablet	2021-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levamlodipine	Xspire Pharma, LLC \| CSPC OUYI PHARMACEUTICAL CO., LTD	2021-11-18	HUMAN PRESCRIPTION DRUG LABEL	1