TRANYLCYPROMINE SULFATE

Product NDC
64380-176
11-digit product format
643800176
Labeler code
64380
Product ID
64380-176_8f68f947-b896-4164-87bf-1bddc7afb6b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tranylcypromine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA040640
Marketing category
ANDA
Marketing start
2022-04-11
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
A040640-001TRANYLCYPROMINE SULFATETRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040640-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040640-001TRANYLCYPROMINE SULFATEEQ 10MG BASETABLET / ORALAB2006-06-29e64feba35796…

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 06:07:402026-07A040640-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040640-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040640-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040640-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040640-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040640-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040640-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040640-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040640-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040640-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040640-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040640-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040640-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040640-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040640-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040640-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040640-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040640-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040640-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040640-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040640-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040640-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040640-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040640-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040640-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040640-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040640-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040640-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040640-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040640-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040640-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040640-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040640-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040640-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040640-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040640-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040640-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040640-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040640-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040640-001AB1e64feba35796…

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
7974d4ad-c419-4c7f-bbd6-f631d53e30deAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e5d23806-15ec-bf11-70d3-a53de2b06bf6Product name320230314
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-176-01TRANYLCYPROMINE SULFATE100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-176-01EA - Each64380-176ce91bb14-5ffc-44c1-a1c0-c6a1065b8e8f12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-176TRANYLCYPROMINE SULFATE TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED]3Current NDC, Legacy NDC, 1 package rows20230527_7974d4ad-c419-4c7f-bbd6-f631d53e30de.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRANYLCYPROMINE SULFATETRANYLCYPROMINE SULFATEStrides Pharma Science Limited7974d4ad-c419-4c7f-bbd6-f631d53e30de2023-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040640
application number: ANDA040640
ndc (product): 64380-176

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313447tranylcypromine sulfate 10 MG Oral TabletPSN7974d4ad-c419-4c7f-bbd6-f631d53e30de3
313447tranylcypromine 10 MG Oral TabletSCD7974d4ad-c419-4c7f-bbd6-f631d53e30de3
313447tranylcypromine (as tranylcypromine sulfate) 10 MG Oral TabletSY7974d4ad-c419-4c7f-bbd6-f631d53e30de3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64380-176-0164380017601100 TABLET, FILM COATED in 1 BOTTLE (64380-176-01) 2022-04-110000-00-00NoNoCurrent