Home NDC 33342-388 Desvenlafaxine Succinate
Product NDC 33342-388
11-digit product format 333420388
Labeler code 33342
Product ID 33342-388_edf18b33-a226-44f8-9f42-c409e691ee64
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desvenlafaxine Succinate
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA211427
Marketing category ANDA
Marketing start 2020-07-30
Substance DESVENLAFAXINE SUCCINATE
Active strength 50 mg/1
Pharmacologic classes Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211427-001 DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 A211427-002 DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-08-18 06:07:40 2026-07 A211427-001 DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211427-002 DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211427-001 DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211427-002 DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211427-001 DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211427-002 DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211427-001 DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211427-002 DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211427-001 DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211427-002 DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211427-001 DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211427-002 DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211427-001 DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211427-002 DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-01-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Desvenlafaxine Succinate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESVENLAFAXINE SUCCINATE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZB22ENF0XR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1874553 Internal RxNorm lookup 1874559 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 33342-388-07 Desvenlafaxine Succinate 30 in 1 BOTTLE TABLET, EXTENDED RELEASE 30 1 33342-388-10 Desvenlafaxine Succinate 90 in 1 BOTTLE TABLET, EXTENDED RELEASE 90 1 33342-388-12 Desvenlafaxine Succinate 10 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 10 1 33342-388-12 Desvenlafaxine Succinate 10 in 1 CARTON TABLET, EXTENDED RELEASE 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-388 DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 4 package rows 20250412_edf18b33-a226-44f8-9f42-c409e691ee64.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 Sample Exclude flag Status 33342-388-07 33342038807 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-388-07) 2020-07-30 No No Current 33342-388-10 33342038810 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-388-10) 2020-07-30 No No Current 33342-388-12 33342038812 10 BLISTER PACK in 1 CARTON (33342-388-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 10 blister pack 2020-07-30 No No Current