Tranylcypromine Sulfate

Product NDC
47781-517
Requested package NDC
47781-517-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage47781-51747781-517-01DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206856-001TRANYLCYPROMINE SULFATETRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206856-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206856-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2018-04-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206856-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206856-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206856-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206856-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206856-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206856-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206856-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206856-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206856-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206856-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206856-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206856-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206856-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206856-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206856-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206856-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206856-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206856-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206856-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206856-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206856-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206856-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206856-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206856-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206856-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206856-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206856-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206856-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206856-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206856-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206856-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206856-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206856-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206856-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206856-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206856-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206856-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206856-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206856-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206856-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-517-01EA - Each47781-517239bf717-eff5-4f65-859c-bf548e7bab2612019-04-11

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TranylcypromineTRANYLCYPROMINENovitium Pharma LLC8ab1c887-76fb-44ca-9999-4eefd3778cfc2021-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206856
application number: ANDA206856

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-517-0147781051701100 TABLET, FILM COATED in 1 BOTTLE (47781-517-01) 2019-02-042021-08-01NoNoCurrent