Desvenlafaxine Succinate
- Product NDC
- 50090-4069
- 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
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 50090-4069 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 50090-4069 | 50090-4069-0 | I | Inactivated by FDA | 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.
| 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 | 50090-4069-0 | 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 | 50090-4069-0 | 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 | 50090-4069-0 | 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 | 50090-4069-0 | 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 | 50090-4069-0 | 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 | 50090-4069-0 | 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 | 50090-4069-0 | 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 | 50090-4069-0 | 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 | 50090-4069-0 | 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 | 50090-4069-0 | 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 | 50090-4069-0 | 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 | 50090-4069-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-4069-0 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-4069-0 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-4069-0 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| N021992-001 | AB |
| N021992-002 | AB |
| N021992-003 | AB |
Orange Book patents#
| 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 | 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#
| 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#
| Captured | Edition | Application-product | Patent | Expiration | Use code | 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 | 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 Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a9aae381-3b13-08a9-c49d-484a2c2a6dc8 | Product name | 7 | 20251106 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 99b326f2-4886-9fc8-8686-faef7b7f27dd | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4069-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-bd7f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DESVENLAFAXINE SUCCINATE safely and effectively. See full prescribing information for DESVENLAFAXINE SUCCINATE. Desvenlafaxine Succinate Extended-Release Tablets, for oral use Initial U.S. Approval: 2008 |
DailyMed Package Descriptions#
| 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 | 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 |
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.
| 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 | 021992 NDA021992 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1874559 | desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet | PSN | 194cfe3f-7831-4eae-823c-bfc5c715a590 | 1 |
| 1874559 | 24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet | SCD | 194cfe3f-7831-4eae-823c-bfc5c715a590 | 1 |
| 1874559 | desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet | SY | 194cfe3f-7831-4eae-823c-bfc5c715a590 | 1 |
Packages#
| 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 |