Trandolapril

Product NDC: 50090-4120
11-digit product format: 500904120
Labeler code: 50090
Product ID: 50090-4120_405b8a4d-2b70-4623-a3f1-cabe09349c99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trandolapril
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078438
Marketing category: ANDA
Marketing start: 2007-06-12
Marketing end: 0000-00-00
Substance: TRANDOLAPRIL
Active strength: 2 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-4120		I	Inactivated by FDA	2026-08-10
excluded package	package	50090-4120	50090-4120-0	I	Inactivated by FDA	2026-08-10
excluded package	package	50090-4120	50090-4120-1	I	Inactivated by FDA	2026-08-10

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 · 45 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	50090-4120-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4120-0	`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	50090-4120-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4120-0	`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	50090-4120-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4120-0	`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	50090-4120-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4120-0	`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	50090-4120-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4120-0	`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	50090-4120-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4120-0	`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	50090-4120-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-4120-0	`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	50090-4120-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-4120-0	`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	50090-4120-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-4120-0	`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	50090-4120-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-4120-0	`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	50090-4120-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-4120-0	`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	50090-4120-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-4120-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4120-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4120-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4120-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4120-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4120-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4120-0	`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	TE codes	Approval date
A078438-001	TRANDOLAPRIL	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12
A078438-002	TRANDOLAPRIL	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12
A078438-003	TRANDOLAPRIL	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078438-001	AB
A078438-002	AB
A078438-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078438-002	TRANDOLAPRIL	2MG	TABLET / ORAL	AB	2007-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078438-003	TRANDOLAPRIL	4MG	TABLET / ORAL	AB	2007-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078438-001	TRANDOLAPRIL	1MG	TABLET / ORAL	AB	2007-06-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078438-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078438-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078438-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078438-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078438-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078438-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078438-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078438-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078438-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078438-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078438-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078438-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078438-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078438-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078438-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078438-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078438-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078438-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078438-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078438-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078438-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078438-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078438-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078438-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078438-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078438-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078438-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078438-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078438-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078438-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078438-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078438-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078438-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078438-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078438-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078438-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078438-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078438-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078438-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078438-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
980ce3cc-8943-91ef-56b2-a0bae7a2b9f9	Product name	1	20140508
d3b67bc2-0e96-e3ec-06a9-90afcc07bf13	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4120-0	Trandolapril	30 in 1 BOTTLE	TABLET	30		4
50090-4120-1	Trandolapril	90 in 1 BOTTLE, PLASTIC	TABLET	90		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4120	TRANDOLAPRIL TABLET [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 2 package rows	20190501_1d778603-13cb-4110-9d45-8df3438d13ca.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trandolapril	TRANDOLAPRIL	Bryant Ranch Prepack	57f8aac6-3bd3-4ae1-aab2-759c8bc23292	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078438 application number: ANDA078438
Trandolapril	TRANDOLAPRIL	Aurobindo Pharma Limited	6f25ed16-e5e9-4170-b4b4-3b460887779e	2024-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078438 application number: ANDA078438
Trandolapril	TRANDOLAPRIL	Rising Pharma Holdings, Inc.	0107d19a-b43a-4a36-8b8c-4dfc247630e9	2024-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078438 application number: ANDA078438

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1T0N3G9CRC	TRANDOLAPRIL	87679-37-6	TRANDOLAPRIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199351	trandolapril 2 MG Oral Tablet	PSN	1d778603-13cb-4110-9d45-8df3438d13ca	4
199351	trandolapril 2 MG Oral Tablet	SCD	1d778603-13cb-4110-9d45-8df3438d13ca	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4120-0	50090412000	30 TABLET in 1 BOTTLE (50090-4120-0)	30 tablet	2019-02-02	0000-00-00	No	No	Current
50090-4120-1	50090412001	90 TABLET in 1 BOTTLE, PLASTIC (50090-4120-1)	90 tablet	2014-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trandolapril Tablets USP Rx only	A-S Medication Solutions	2019-04-30	Human Prescription Drug Label	4