Tranylcypromine Sulfate

Product NDC: 47781-517
11-digit product format: 477810517
Labeler code: 47781
Product ID: 47781-517_749d9250-b996-b5e5-099f-4455911cab0b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tranylcypromine Sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alvogen Inc.
Application: ANDA206856
Marketing category: ANDA
Marketing start: 2018-04-17
Marketing end: 2021-08-01
Substance: TRANYLCYPROMINE SULFATE
Active strength: 10 mg/1
Pharmacologic classes: Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	47781-517		D	Discontinued by firm		2026-08-03
excluded package	package	47781-517	47781-517-01	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	47781-517		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	47781-517	47781-517-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A206856-001	TRANYLCYPROMINE SULFATE	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB		2018-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206856-001	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 2 · 41 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	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206856-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2018-04-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A206856-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206856-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206856-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206856-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206856-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206856-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206856-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206856-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206856-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206856-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206856-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206856-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206856-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206856-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206856-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206856-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206856-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206856-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206856-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206856-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206856-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206856-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206856-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206856-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206856-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206856-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206856-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206856-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206856-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206856-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206856-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206856-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206856-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206856-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206856-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206856-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206856-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206856-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206856-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206856-001	AB	1	`cb3db0bc1861…`

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
Tranylcypromine	TRANYLCYPROMINE	Novitium Pharma LLC	8ab1c887-76fb-44ca-9999-4eefd3778cfc	2021-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206856 application number: ANDA206856

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-517-01	EA - Each	47781-517	239bf717-eff5-4f65-859c-bf548e7bab26	1	2019-04-11

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7ZAT6ES870	TRANYLCYPROMINE SULFATE	13492-01-8	TRANYLCYPROMINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-517-01	47781051701	100 TABLET, FILM COATED in 1 BOTTLE (47781-517-01)	2019-02-04	2021-08-01	No	No	Current