Tranylcypromine

Product NDC: 43547-655
Requested package NDC: 43547-655-10
11-digit product format: 435470655
Labeler code: 43547
Product ID: 43547-655_df2e24b3-c948-4f36-863c-589296f651fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRANYLCYPROMINE
Dosage form: TABLET
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA213503
Marketing category: ANDA
Marketing start: 2022-12-10
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: 2026-12-31
Current FDA listing: Yes

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 · 6 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
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213503-001	TRANYLCYPROMINE SULFATE	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB		2022-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213503-001	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.

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	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213503-001	TRANYLCYPROMINE SULFATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213503-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213503-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213503-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213503-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213503-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213503-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213503-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213503-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213503-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213503-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213503-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213503-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213503-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213503-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213503-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213503-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213503-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213503-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213503-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213503-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213503-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213503-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213503-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213503-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213503-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213503-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213503-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213503-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tranylcypromine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRANYLCYPROMINE SULFATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7ZAT6ES870	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313447	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3c14a558-2df4-4d93-97dd-640dec6ee785	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e5d23806-15ec-bf11-70d3-a53de2b06bf6	Product name	3	20230314
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43547-655-10	2024-12-20	C162847	48780-1	1030e365-62bb-111a-e063-dadaa90a10e2	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
43547-655-10	2024-01-30	C162847	48780-1	1030e365-62bb-111a-e063-dadaa90a10e2	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
43547-655-10	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
43547-655-10	EA - Each	43547-655	fc629c55-d1a8-4075-abd4-d6028aa7cde8	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-655	TRANYLCYPROMINE TABLET [SOLCO HEALTHCARE US, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20241225_3c14a558-2df4-4d93-97dd-640dec6ee785.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tranylcypromine	TRANYLCYPROMINE	REMEDYREPACK INC.	83942f11-e10c-4c2d-ad78-880e1886064d	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213503 application number: ANDA213503
Tranylcypromine	TRANYLCYPROMINE	Solco Healthcare US, LLC	3c14a558-2df4-4d93-97dd-640dec6ee785	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213503 application number: ANDA213503 ndc (package): 43547-655-10 ndc (product): 43547-655 ndc11 (package): 43547065510

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	3c14a558-2df4-4d93-97dd-640dec6ee785	3
313447	tranylcypromine 10 MG Oral Tablet	SCD	3c14a558-2df4-4d93-97dd-640dec6ee785	3
313447	tranylcypromine (as tranylcypromine sulfate) 10 MG Oral Tablet	SY	3c14a558-2df4-4d93-97dd-640dec6ee785	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-655-10	43547065510	100 TABLET in 1 BOTTLE (43547-655-10)	100 tablet	2022-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tranylcypromine	REMEDYREPACK INC.	2026-07-22	HUMAN PRESCRIPTION DRUG LABEL	1
Tranylcypromine	Solco Healthcare US, LLC \| RIVOPHARM SA	2024-12-20	HUMAN PRESCRIPTION DRUG LABEL	3