Home NDC 70518-4708 Tranylcypromine
Product NDC 70518-4708
11-digit product format 705184708
Labeler code 70518
Product ID 70518-4708_57321a72-7260-30d4-e063-6394a90a3fb3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRANYLCYPROMINE
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA213503
Marketing category ANDA
Marketing start 2026-07-21
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A213503-001 TRANYLCYPROMINE SULFATE TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213503-001 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.
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 2026-09-14 22:38:34 2026-08 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213503-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2022-06-27 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tranylcypromine
Listing expiration 2027-12-31 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4708-0 70518470800 100 POUCH in 1 BOX (70518-4708-0) / 1 TABLET in 1 POUCH (70518-4708-1) 100 pouch 2026-07-21 No No Current