Pristiq
- Product NDC
- 0008-1211
- 11-digit product format
- 000081211
- Labeler code
- 0008
- Product ID
- 0008-1211_b9acfefd-10c0-4942-9446-18bb456efb68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- desvenlafaxine succinate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Application
- NDA021992
- Marketing category
- NDA
- Marketing start
- 2008-05-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021992-002 | PRISTIQ | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-02-29 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021992-003 | PRISTIQ | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2014-08-20 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021992-001 | PRISTIQ | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-02-29 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021992-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021992-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021992-001 | AB | 1 | 8072bd15b7f6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021992-002 | 8269040 | 2027-07-05 | Drug substance | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021992-003 | 8269040 | 2027-07-05 | Drug substance | 2015-02-02 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021992-001 | 8269040 | 2027-07-05 | Drug substance | 8072bd15b7f6… |
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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pristiq
- Brand name suffix
- Extended-Release
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DESVENLAFAXINE SUCCINATE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| ZB22ENF0XR | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0f43610c-f290-46ea-d186-4f998ed99fce | Available on FDA.report |
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0008-1211-01 | PristiqExtended-Release | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | 67 | |
| 0008-1211-14 | PristiqExtended-Release | 14 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 14 | 67 | |
| 0008-1211-30 | PristiqExtended-Release | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | 67 | |
| 0008-1211-50 | PristiqExtended-Release | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | 67 | |
| 0008-1211-50 | PristiqExtended-Release | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 67 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0008-1211-01 | EA - Each | 0008-1211 | d4213829-8cc2-4e1e-943c-3c2affb87d77 | 1 | 2012-07-24 |
| 0008-1211-14 | EA - Each | 0008-1211 | 2b330d69-6976-450b-adf7-399695ee02fa | 1 | 2012-07-24 |
| 0008-1211-30 | EA - Each | 0008-1211 | a4f1b618-aecf-4469-98c4-8eb2798c5526 | 1 | 2012-07-24 |
| 0008-1211-50 | EA - Each | 0008-1211 | a4467bd9-5427-4027-aa6f-6438b7812711 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0008-1211 | PRISTIQ EXTENDED-RELEASE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] | 64 | Current NDC, Legacy NDC, 5 package rows | 20241219_0f43610c-f290-46ea-d186-4f998ed99fce.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 0008-1211 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1874553 | desvenlafaxine succinate 100 MG 24HR Extended Release Oral Tablet | PSN | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1607617 | desvenlafaxine succinate 25 MG 24HR Extended Release Oral Tablet | PSN | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1874559 | desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet | PSN | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 790267 | Pristiq 100 MG 24HR Extended Release Oral Tablet | PSN | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1607619 | Pristiq 25 MG 24HR Extended Release Oral Tablet | PSN | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 790290 | Pristiq 50 MG 24HR Extended Release Oral Tablet | PSN | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 790267 | 24 HR desvenlafaxine succinate 100 MG Extended Release Oral Tablet [Pristiq] | SBD | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1607619 | 24 HR desvenlafaxine succinate 25 MG Extended Release Oral Tablet [Pristiq] | SBD | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 790290 | 24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet [Pristiq] | SBD | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1874553 | 24 HR desvenlafaxine succinate 100 MG Extended Release Oral Tablet | SCD | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1607617 | 24 HR desvenlafaxine succinate 25 MG Extended Release Oral Tablet | SCD | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1874559 | 24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet | SCD | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 790267 | 24 HR Pristiq 100 MG Extended Release Oral Tablet | SY | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1607619 | 24 HR Pristiq 25 MG Extended Release Oral Tablet | SY | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 790290 | 24 HR Pristiq 50 MG Extended Release Oral Tablet | SY | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1874553 | desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral Tablet | SY | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1607617 | desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral Tablet | SY | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1874559 | desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet | SY | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 790267 | Pristiq 100 MG (as desvenlafaxine succinate 152 MG) 24 HR Extended Release Oral Tablet | SY | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1607619 | Pristiq 25 MG (as desvenlafaxine succinate 38 MG) 24 HR Extended Release Oral Tablet | SY | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 790290 | Pristiq 50 MG (as desvenlafaxine succinate 76 MG) 24 HR Extended Release Oral Tablet | SY | 0f43610c-f290-46ea-d186-4f998ed99fce | 67 |
| 1874559 | desvenlafaxine succinate 50 MG 24HR Extended Release Oral Tablet | PSN | 32d632f6-e7cc-455e-bd9a-3dcfc99a794f | 1 |
| 790290 | Pristiq 50 MG 24HR Extended Release Oral Tablet | PSN | 32d632f6-e7cc-455e-bd9a-3dcfc99a794f | 1 |
| 790290 | 24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet [Pristiq] | SBD | 32d632f6-e7cc-455e-bd9a-3dcfc99a794f | 1 |
| 1874559 | 24 HR desvenlafaxine succinate 50 MG Extended Release Oral Tablet | SCD | 32d632f6-e7cc-455e-bd9a-3dcfc99a794f | 1 |
| 790290 | 24 HR Pristiq 50 MG Extended Release Oral Tablet | SY | 32d632f6-e7cc-455e-bd9a-3dcfc99a794f | 1 |
| 1874559 | desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral Tablet | SY | 32d632f6-e7cc-455e-bd9a-3dcfc99a794f | 1 |
| 790290 | Pristiq 50 MG (as desvenlafaxine succinate 76 MG) 24 HR Extended Release Oral Tablet | SY | 32d632f6-e7cc-455e-bd9a-3dcfc99a794f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0008-1211-01 | 00008121101 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-01) | 2008-05-01 | 0000-00-00 | No | No | Current | |
| 0008-1211-14 | 00008121114 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-14) | 2008-05-01 | 0000-00-00 | No | No | Current | |
| 0008-1211-30 | 00008121130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-30) | 2008-05-01 | 0000-00-00 | No | No | Current | |
| 0008-1211-50 | 00008121150 | 100 BLISTER PACK in 1 CARTON (0008-1211-50) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 2008-05-01 | 0000-00-00 | No | No | Current |