Tranylcypromine Sulfate

Product NDC
0591-5590
11-digit product format
005915590
Labeler code
0591
Product ID
0591-5590_e42c8b23-863e-4370-a3b1-b71526b12ee5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tranylcypromine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA012342
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-02-05
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N012342-003PARNATETRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N012342-003AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-163f01610625f2…
2019-09-15 20:21 UTC2019-09N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N012342-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N012342-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012342-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N012342-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012342-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012342-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012342-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012342-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012342-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012342-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N012342-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N012342-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N012342-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N012342-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N012342-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N012342-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N012342-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N012342-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N012342-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N012342-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N012342-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N012342-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N012342-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N012342-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N012342-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N012342-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N012342-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N012342-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N012342-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N012342-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N012342-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N012342-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N012342-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N012342-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N012342-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N012342-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N012342-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N012342-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N012342-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N012342-003AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANYLCYPROMINE SULFATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ZAT6ES870Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a0b609b-0625-4c26-91a1-59ee3ece3ddfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5d23806-15ec-bf11-70d3-a53de2b06bf6Product name320230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5590-01Tranylcypromine Sulfate100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5590-01EA - Each0591-5590f89d1621-62c5-4bb7-a001-892f05d79a9612016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5590TRANYLCYPROMINE SULFATE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]7Current NDC, Legacy NDC, 1 package rows20220316_6a0b609b-0625-4c26-91a1-59ee3ece3ddf.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tranylcypromine SulfateTRANYLCYPROMINE SULFATEActavis Pharma, Inc.6a0b609b-0625-4c26-91a1-59ee3ece3ddf2025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 012342
application number: NDA012342
ndc (product): 0591-5590
PARNATETRANYLCYPROMINE SULFATEAdvanz Pharma (US) Corp.b72d8187-dfcc-4ea0-b5e9-c0be95b69a272025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 012342
application number: NDA012342

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313447tranylcypromine sulfate 10 MG Oral TabletPSN6a0b609b-0625-4c26-91a1-59ee3ece3ddf8
313447tranylcypromine 10 MG Oral TabletSCD6a0b609b-0625-4c26-91a1-59ee3ece3ddf8
313447tranylcypromine (as tranylcypromine sulfate) 10 MG Oral TabletSY6a0b609b-0625-4c26-91a1-59ee3ece3ddf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-5590-0100591559001100 TABLET, FILM COATED in 1 BOTTLE (0591-5590-01) 2016-02-050000-00-00NoNoCurrent