Home NDC 50090-4069-0 Desvenlafaxine Succinate
Product NDC 50090-4069
Requested package NDC 50090-4069-0
11-digit product format 500904069
Labeler code 50090
Product ID 50090-4069_ce48638d-3ca2-48d8-af3b-532e0a60e654
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name desvenlafaxine succinate
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler A-S Medication Solutions
Application NDA021992
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2017-03-01
Marketing end 0000-00-00
Substance DESVENLAFAXINE SUCCINATE
Active strength 50 mg/1
Pharmacologic classes Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021992-001 PRISTIQ DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2008-02-29 N021992-002 PRISTIQ DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2008-02-29 N021992-003 PRISTIQ DESVENLAFAXINE SUCCINATE EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2014-08-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021992-001 8269040 2027-07-05 Drug substance N021992-002 8269040 2027-07-05 Drug substance N021992-003 8269040 2027-07-05 Drug substance 2015-02-02
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 N021992-001 PRISTIQ EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2008-02-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N021992-002 PRISTIQ EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2008-02-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N021992-003 PRISTIQ EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2014-08-20 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N021992-001 8269040 2027-07-05 Drug substance a50c72e98297…2026-08-01 22:54:32 2026-06 N021992-002 8269040 2027-07-05 Drug substance a50c72e98297…2026-08-01 22:54:32 2026-06 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pristiq Extended-Release DESVENLAFAXINE SUCCINATE Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0f43610c-f290-46ea-d186-4f998ed99fce 2026-04-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021992 application number: NDA021992
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4069-0 Desvenlafaxine Succinate 30 in 1 BOTTLE, PLASTIC TABLET, EXTENDED RELEASE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4069 DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] 1 Legacy NDC, 1 package rows 20190123_194cfe3f-7831-4eae-823c-bfc5c715a590.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 50090-4069-0 50090406900 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-4069-0) 2019-01-18 0000-00-00 No No Current