Home NDC 64380-176 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 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 A040640-001 TRANYLCYPROMINE SULFATE TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2006-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040640-001 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 2026-08-01 22:54:32 2026-06 A040640-001 TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET / ORAL AB 2006-06-29 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A040640-001 AB 1 a50c72e98297…
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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base TRANYLCYPROMINE SULFATE
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 64380-176-01 TRANYLCYPROMINE SULFATE 100 in 1 BOTTLE TABLET, FILM COATED 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-176 TRANYLCYPROMINE SULFATE TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED] 3 Current NDC, Legacy NDC, 1 package rows 20230527_7974d4ad-c419-4c7f-bbd6-f631d53e30de.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64380-176-01 64380017601 100 TABLET, FILM COATED in 1 BOTTLE (64380-176-01) 2022-04-11 0000-00-00 No No Current