PARNATE

Product NDC
59212-447
11-digit product format
592120447
Labeler code
59212
Product ID
59212-447_1e311326-d555-4a01-91a5-f53077a450c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tranylcypromine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanz Pharma (US) Corp.
Application
NDA012342
Marketing category
NDA
Marketing start
2013-01-14
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…

Additional Listing Data#

Finished product
Yes
Brand name base
PARNATE
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
104838Internal RxNorm lookup
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
b72d8187-dfcc-4ea0-b5e9-c0be95b69a27Available 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
59212-447-10PARNATE100 in 1 BOTTLETABLET, FILM COATED10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59212-447-10EA - Each59212-447f2e385aa-1d5f-465e-b4be-13641d8d380a12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-447PARNATE (TRANYLCYPROMINE SULFATE) TABLET, FILM COATED [ADVANZ PHARMA (US) CORP.]10Current NDC, Legacy NDC, 1 package rows20241220_b72d8187-dfcc-4ea0-b5e9-c0be95b69a27.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
PARNATETRANYLCYPROMINE SULFATEAdvanz Pharma (US) Corp.b72d8187-dfcc-4ea0-b5e9-c0be95b69a272025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 012342
application number: NDA012342
ndc (product): 59212-447

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104838Parnate 10 MG Oral TabletPSNb72d8187-dfcc-4ea0-b5e9-c0be95b69a2711
313447tranylcypromine sulfate 10 MG Oral TabletPSNb72d8187-dfcc-4ea0-b5e9-c0be95b69a2711
104838tranylcypromine 10 MG Oral Tablet [Parnate]SBDb72d8187-dfcc-4ea0-b5e9-c0be95b69a2711
313447tranylcypromine 10 MG Oral TabletSCDb72d8187-dfcc-4ea0-b5e9-c0be95b69a2711
104838Parnate 10 MG (as tranylcypromine sulfate) Oral TabletSYb72d8187-dfcc-4ea0-b5e9-c0be95b69a2711
104838Parnate 10 MG Oral TabletSYb72d8187-dfcc-4ea0-b5e9-c0be95b69a2711
313447tranylcypromine (as tranylcypromine sulfate) 10 MG Oral TabletSYb72d8187-dfcc-4ea0-b5e9-c0be95b69a2711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59212-447-1059212044710100 TABLET, FILM COATED in 1 BOTTLE (59212-447-10) 2013-01-140000-00-00NoNoCurrent