Home NDC 70954-538 Tranylcypromine
Product NDC 70954-538
11-digit product format 709540538
Labeler code 70954
Product ID 70954-538_8ab1c887-76fb-44ca-9999-4eefd3778cfc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tranylcypromine
Dosage form TABLET
Route ORAL
Labeler Novitium Pharma LLC
Application ANDA206856
Marketing category ANDA
Marketing start 2021-06-06
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206856-001 TRANYLCYPROMINE SULFATE TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206856-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206856-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2018-04-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tranylcypromine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRANYLCYPROMINE SULFATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7ZAT6ES870 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313447 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70954-538-10 Tranylcypromine 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-538 TRANYLCYPROMINE TABLET [NOVITIUM PHARMA LLC] 1 Current NDC, Legacy NDC, 1 package rows 20210622_8ab1c887-76fb-44ca-9999-4eefd3778cfc.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70954-538-10 70954053810 100 TABLET in 1 BOTTLE (70954-538-10) 100 tablet 2021-06-06 0000-00-00 No No Current