Tranylcypromine

Product NDC: 10135-739
11-digit product format: 101350739
Labeler code: 10135
Product ID: 10135-739_df892a6f-3d0f-ea21-e053-2a95a90a9ece
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tranylcypromine
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals, Inc.
Application: ANDA206856
Marketing category: ANDA
Marketing start: 2022-05-01
Marketing end: 0000-00-00
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10135-739		I	Inactivated by FDA		2026-08-03
excluded package	package	10135-739	10135-739-01	I	Inactivated by FDA		2026-08-03

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e5d23806-15ec-bf11-70d3-a53de2b06bf6	Product name	3	20230314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-739-01	2026-01-29	C162847	48780-1	49896155-aaa5-586f-e063-e6dba90add90	These highlights do not include all the information needed to use TRANYLCYPROMINE TABLETS safely and effectively. See full prescribing information for TRANYLCYPROMINE TABLETS. TRANYLCYPROMINE tablets, for oral use Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-739-01	Tranylcypromine	100 in 1 BOTTLE	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-739-01	EA - Each	10135-739	e312a26f-4114-4431-8397-36b6ae19ae2a	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-739	TRANYLCYPROMINE TABLET [MARLEX PHARMACEUTICALS, INC.]	3	Legacy NDC, 1 package rows	20241019_df892a65-52e4-8eb2-e053-2a95a90aa25f.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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7ZAT6ES870	TRANYLCYPROMINE SULFATE	13492-01-8	TRANYLCYPROMINE SULFATE
3E3V44J4Z9	TRANYLCYPROMINE	155-09-9	Tranylcypromine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313447	tranylcypromine sulfate 10 MG Oral Tablet	PSN	df892a65-52e4-8eb2-e053-2a95a90aa25f	3
313447	tranylcypromine 10 MG Oral Tablet	SCD	df892a65-52e4-8eb2-e053-2a95a90aa25f	3
313447	tranylcypromine (as tranylcypromine sulfate) 10 MG Oral Tablet	SY	df892a65-52e4-8eb2-e053-2a95a90aa25f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-739-01	10135073901	100 TABLET in 1 BOTTLE (10135-739-01)	100 tablet	2022-05-01	0000-00-00	No	No	Current