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 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
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 · 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 UTC2026-02N012342-003PARNATEEQ 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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012342-003PARNATEEQ 10MG BASETABLET / ORALABRLD, RS1985-08-16cb3db0bc1861…

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 UTC2026-02N012342-003AB1011fe1cb6892…
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012342-003AB1cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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