Conjupri

Product NDC: 69101-550
11-digit product format: 691010550
Labeler code: 69101
Product ID: 69101-550_cbf5c44c-aa51-4acf-e053-2a95a90aa6ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levamlodipine
Dosage form: TABLET
Route: ORAL
Labeler: Burke Therapeutics, LLC
Application: NDA212895
Marketing category: NDA
Marketing start: 2020-09-01
Marketing end: 2022-08-11
Substance: LEVAMLODIPINE MALEATE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69101-550		D	Discontinued by firm	2026-08-03
excluded package	package	69101-550	69101-550-30	D	Discontinued by firm	2026-08-03
excluded package	package	69101-550	69101-550-50	D	Discontinued by firm	2026-08-03
excluded package	package	69101-550	69101-550-90	D	Discontinued by firm	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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69101-550-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69101-550-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69101-550-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69101-550-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69101-550-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69101-550-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69101-550-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69101-550-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69101-550-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69101-550-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69101-550-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69101-550-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69101-550-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69101-550-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69101-550-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69101-550-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69101-550-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69101-550-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69101-550-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69101-550-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69101-550-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69101-550-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69101-550-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69101-550-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69101-550-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69101-550-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69101-550-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69101-550-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69101-550-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69101-550-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69101-550-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69101-550-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69101-550-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69101-550-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69101-550-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69101-550-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69101-550-30	69101055030	30 TABLET in 1 BOTTLE (69101-550-30)	30 tablet	2020-09-01	0000-00-00	No	No	Current
69101-550-50	69101055050	500 TABLET in 1 BOTTLE (69101-550-50)	500 tablet	2020-09-01	0000-00-00	No	No	Current
69101-550-90	69101055090	90 TABLET in 1 BOTTLE (69101-550-90)	90 tablet	2020-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Conjupri	Burke Therapeutics, LLC \| CSPC OUYI PHARMACEUTICAL CO., LTD	2021-09-14	HUMAN PRESCRIPTION DRUG LABEL	3