Pristiq

Product NDC: 43063-262
11-digit product format: 430630262
Labeler code: 43063
Product ID: 43063-262_e34eea95-9c4c-939f-e053-2995a90a6b58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: desvenlafaxine succinate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: NDA021992
Marketing category: NDA
Marketing start: 2008-05-01
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43063-262		D	Discontinued by firm		2026-08-17
excluded package	package	43063-262	43063-262-30	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-262-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-262-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-262-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-262-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-262-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-262-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-262-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-262-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-262-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-262-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-262-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-262-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Application-product, TE code table
Application-product	TE code
N021992-001	AB
N021992-002	AB
N021992-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	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.

Product history page 1 of 4 · 126 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
2026-08-18 06:07:40	2026-07	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-002	PRISTIQ	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-02-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-003	PRISTIQ	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-001	PRISTIQ	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-02-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021992-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021992-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021992-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021992-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021992-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021992-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-001	AB	1	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 234 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021992-001	8269040	2027-07-05	Drug substance		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021992-002	8269040	2027-07-05	Drug substance		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021992-001	8269040	2027-07-05	Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-002	8269040	2027-07-05	Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-001	8269040	2027-07-05	Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-002	8269040	2027-07-05	Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021992-001	8269040	2027-07-05	Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-002	8269040	2027-07-05	Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-001	8269040	2027-07-05	Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-002	8269040	2027-07-05	Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-001	8269040	2027-07-05	Drug substance		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-002	8269040	2027-07-05	Drug substance		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-001	8269040	2027-07-05	Drug substance		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-002	8269040	2027-07-05	Drug substance		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-001	8269040	2027-07-05	Drug substance		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-002	8269040	2027-07-05	Drug substance		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-001	8269040	2027-07-05	Drug substance		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-002	8269040	2027-07-05	Drug substance		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-001	8269040	2027-07-05	Drug substance		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-002	8269040	2027-07-05	Drug substance		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021992-001	8269040	2027-07-05	Drug substance		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-002	8269040	2027-07-05	Drug substance		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-001	8269040	2027-07-05	Drug substance		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-002	8269040	2027-07-05	Drug substance		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-001	8269040	2027-07-05	Drug substance		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-002	8269040	2027-07-05	Drug substance		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021992-003	8269040	2027-07-05	Drug substance	2015-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021992-001	8269040	2027-07-05	Drug substance		`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021992-001	M-222	2021-02-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021992-002	M-222	2021-02-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021992-003	M-222	2021-02-06	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021992-001	M-222	2021-02-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021992-002	M-222	2021-02-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021992-003	M-222	2021-02-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021992-001	M-222	2021-02-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021992-002	M-222	2021-02-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021992-003	M-222	2021-02-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021992-001	M-222	2021-02-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021992-002	M-222	2021-02-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021992-003	M-222	2021-02-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021992-001	M-222	2021-02-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021992-002	M-222	2021-02-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021992-003	M-222	2021-02-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021992-001	M-222	2021-02-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021992-002	M-222	2021-02-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021992-003	M-222	2021-02-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021992-001	M-222	2021-02-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021992-002	M-222	2021-02-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021992-003	M-222	2021-02-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021992-001	M-222	2021-02-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021992-002	M-222	2021-02-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021992-003	M-222	2021-02-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021992-001	M-222	2021-02-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021992-002	M-222	2021-02-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021992-003	M-222	2021-02-06	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-262-30	EA - Each	43063-262	1506634c-2b2f-4da6-8eb9-0b3b47b37ef2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DESVENLAFAXINE SUCCINATE	ACTIVE INGREDIENT	ZB22ENF0XR	PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	1
DESVENLAFAXINE	ACTIVE MOIETY	NG99554ANW	PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	1
HYPROMELLOSE 2208 (15000 CPS)	INACTIVE INGREDIENT	Z78RG6M2N2	PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	1

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.

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZB22ENF0XR	DESVENLAFAXINE SUCCINATE	386750-22-7	DESVENLAFAXINE SUCCINATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-262-30	43063026230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-262-30)	2010-05-12	0000-00-00	No	No	Current