DESVENLAFAXINE
- Product NDC
- 68071-5332
- 11-digit product format
- 680715332
- Labeler code
- 68071
- Product ID
- 68071-5332_5d43be79-0960-519f-e063-6294a90ae2ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DESVENLAFAXINE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA204028
- Marketing category
- ANDA
- Marketing start
- 2025-05-02
- 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 |
|---|---|---|---|---|---|---|---|
| A204028-001 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | |
| A204028-002 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | |
| A204028-003 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204028-001 | AB |
| A204028-002 | AB |
| A204028-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204028-002 | DESVENLAFAXINE SUCCINATE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204028-003 | DESVENLAFAXINE SUCCINATE | EQ 25MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-12-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204028-001 | DESVENLAFAXINE SUCCINATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-06-29 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204028-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204028-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204028-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204028-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204028-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204028-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204028-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204028-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204028-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204028-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204028-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204028-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204028-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204028-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204028-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204028-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204028-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204028-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204028-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204028-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204028-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204028-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204028-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204028-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204028-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204028-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204028-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204028-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204028-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204028-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204028-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204028-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204028-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204028-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204028-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204028-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204028-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204028-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204028-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204028-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DESVENLAFAXINE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DESVENLAFAXINE SUCCINATE | 50 mg/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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DESVENLAFAXINE | DESVENLAFAXINE | Advagen Pharma Ltd | ff837eb1-24c3-4c63-9b4b-c6b5935a9b47 | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | 204028 ANDA204028 |
| DESVENLAFAXINE | DESVENLAFAXINE | Bryant Ranch Prepack | 65f4a870-aa91-4d05-a32d-a161295bcc17 | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | 204028 ANDA204028 |
| DESVENLAFAXINE | DESVENLAFAXINE | Bryant Ranch Prepack | 643bfe62-7885-4db4-9fff-5d8552b53d14 | 2026-05-08 | Boxed warning, Warnings, Adverse reactions | 204028 ANDA204028 |
| DESVENLAFAXINE | DESVENLAFAXINE | Preferred Pharmaceuticals Inc. | 5a136b61-f734-43d5-86fc-059ff3b5342a | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 204028 ANDA204028 |
| DESVENLAFAXINE | DESVENLAFAXINE | A-S Medication Solutions | 48d3a09e-850d-472d-8fb2-996a5167b16d | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | 204028 ANDA204028 |
| DESVENLAFAXINE | DESVENLAFAXINE | A-S Medication Solutions | b14695b4-c35e-4902-8144-d31d698b1c58 | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | 204028 ANDA204028 |
| Desvenlafaxine ER | DESVENLAFAXINE ER | Direct_rx | 1d86d1dc-d685-43aa-e063-6294a90a9907 | 2025-05-12 | Boxed warning, Warnings, Adverse reactions | 204028 ANDA204028 |
| DESVENLAFAXINE | DESVENLAFAXINE | NorthStar Rx LLC | 3fcc0555-f9cf-4735-a0ef-830c50c390b8 | 2025-05-07 | Boxed warning, Warnings, Adverse reactions | 204028 ANDA204028 |
| DESVENLAFAXINE | DESVENLAFAXINE | NuCare Pharmaceuticals,Inc. | 2dce1542-ead5-1b24-e063-6294a90a6df0 | 2025-02-17 | Boxed warning, Warnings, Adverse reactions | 204028 ANDA204028 |
| DESVENLAFAXINE | DESVENLAFAXINE | Bryant Ranch Prepack | 5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a4 | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | 204028 ANDA204028 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 68071-5332-3 | 68071533203 | 30 TABLET, EXTENDED RELEASE in 1 PACKAGE (68071-5332-3) | 2026-10-07 | No | No | Current |