Duloxetine
- Product NDC
- 51991-750
- 11-digit product format
- 519910750
- Labeler code
- 51991
- Product ID
- 51991-750_32327581-bdab-41ac-9adc-bf208e1c4e42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DULOXETINE HYDROCHLORIDE
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA203088
- Marketing category
- ANDA
- Marketing start
- 2018-05-21
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203088-001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | |
| A203088-002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | |
| A203088-003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | |
| A203088-004 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203088-001 | AB |
| A203088-002 | AB |
| A203088-003 | AB |
| A203088-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203088-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203088-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203088-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203088-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203088-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203088-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203088-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203088-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203088-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Duloxetine
- Brand name suffix
- Delayed-Release
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DULOXETINE HYDROCHLORIDE | 40 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9044SC542W | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| caef6f50-1571-4ec7-8f8c-42b924d323ee | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| aebfdb62-b550-4c4f-9225-d5d3bbc7ab88 | Product name | 9 | 20210727 |
| 7dd29e28-6b69-499b-9257-12a3b46ca283 | Product name | 1 | 20191120 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51991-750-05 | Duloxetine Delayed-Release | 500 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 500 | 26 | |
| 51991-750-10 | Duloxetine Delayed-Release | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 1000 | 26 | |
| 51991-750-33 | Duloxetine Delayed-Release | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 30 | 26 | |
| 51991-750-90 | Duloxetine Delayed-Release | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 90 | 26 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51991-750-33 | EA - Each | 51991-750 | f301a0c8-2139-4f1b-93e5-b45dec84f400 | 1 | 2018-07-03 |
| 51991-750-90 | EA - Each | 51991-750 | 73dd05eb-32c2-4ede-8ae9-715e783fe2bb | 1 | 2023-02-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51991-750 | DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BRECKENRIDGE PHARMACEUTICAL, INC.] | 26 | Current NDC, Legacy NDC, 4 package rows | 20250209_caef6f50-1571-4ec7-8f8c-42b924d323ee.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 |
|---|---|---|---|---|---|---|
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | b9f20917-9529-4c62-bafe-baae7f8d6c77 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 29eacc40-cbec-4cc9-8556-773346617e85 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine | DULOXETINE HYDROCHLORIDE | Quallent Pharmaceuticals Health, LLC | 31362045-201f-45f3-99f2-a5e322a0c30b | 2025-11-03 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | f535fcd2-a50a-4423-85d9-705fd2d9a470 | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3bae1317-4cc8-4d86-b1b6-15edee733a6d | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 2c233b3f-83de-40c4-9f1d-81f901f89459 | 2025-04-04 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | f66f63c8-51db-4183-a452-78205cf3a263 | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 276ca221-354c-484d-93d5-0698cb2cfd56 | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a23e79b3-7bd3-4b83-beb0-dc23d4830e9e | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a5804a0b-ceae-4ebd-bba0-bfc10e21b90d | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a891f20f-83ff-4960-81ef-9e74d01a452e | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | c934cc41-b40b-4c5c-b019-a749eec52d88 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 00628e5e-4c5b-2573-e063-6294a90a0e3b | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ca36f94c-2215-436f-ada8-7319f4f3e054 | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | b25c01e0-273a-4f8f-a37e-9b17e5cf378f | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | caef6f50-1571-4ec7-8f8c-42b924d323ee | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 51991-750 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | df61b895-c358-827b-e053-2995a90a9b60 | 2024-12-26 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 41876761-9d5b-4190-a200-6a822c54582e | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 0c82422a-d493-4dda-8626-0d9baa25db8c | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ca376622-d32c-4e6e-8af4-8e24a8d20d83 | 2024-08-06 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 616402 | DULoxetine 40 MG Delayed Release Oral Capsule | PSN | 675f999d-46b2-45da-b17e-58cc2ba180b1 | 107 |
| 616402 | duloxetine 40 MG Delayed Release Oral Capsule | SCD | 675f999d-46b2-45da-b17e-58cc2ba180b1 | 107 |
| 616402 | duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule | SY | 675f999d-46b2-45da-b17e-58cc2ba180b1 | 107 |
| 616402 | DULoxetine 40 MG Delayed Release Oral Capsule | PSN | c934cc41-b40b-4c5c-b019-a749eec52d88 | 103 |
| 616402 | duloxetine 40 MG Delayed Release Oral Capsule | SCD | c934cc41-b40b-4c5c-b019-a749eec52d88 | 103 |
| 616402 | duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule | SY | c934cc41-b40b-4c5c-b019-a749eec52d88 | 103 |
| 616402 | DULoxetine 40 MG Delayed Release Oral Capsule | PSN | f66f63c8-51db-4183-a452-78205cf3a263 | 102 |
| 616402 | duloxetine 40 MG Delayed Release Oral Capsule | SCD | f66f63c8-51db-4183-a452-78205cf3a263 | 102 |
| 616402 | duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule | SY | f66f63c8-51db-4183-a452-78205cf3a263 | 102 |
| 596926 | DULoxetine 20 MG Delayed Release Oral Capsule | PSN | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 596930 | DULoxetine 30 MG Delayed Release Oral Capsule | PSN | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 616402 | DULoxetine 40 MG Delayed Release Oral Capsule | PSN | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 596934 | DULoxetine 60 MG Delayed Release Oral Capsule | PSN | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 596926 | duloxetine 20 MG Delayed Release Oral Capsule | SCD | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 596930 | duloxetine 30 MG Delayed Release Oral Capsule | SCD | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 616402 | duloxetine 40 MG Delayed Release Oral Capsule | SCD | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 596934 | duloxetine 60 MG Delayed Release Oral Capsule | SCD | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 596926 | duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule | SY | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 596930 | duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule | SY | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 616402 | duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule | SY | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 596934 | duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule | SY | caef6f50-1571-4ec7-8f8c-42b924d323ee | 26 |
| 616402 | DULoxetine 40 MG Delayed Release Oral Capsule | PSN | 2c233b3f-83de-40c4-9f1d-81f901f89459 | 5 |
| 616402 | duloxetine 40 MG Delayed Release Oral Capsule | SCD | 2c233b3f-83de-40c4-9f1d-81f901f89459 | 5 |
| 616402 | duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule | SY | 2c233b3f-83de-40c4-9f1d-81f901f89459 | 5 |
| 616402 | DULoxetine 40 MG Delayed Release Oral Capsule | PSN | f5e7503a-b28f-4cd0-a4ee-47bdca88d54b | 1 |
| 616402 | duloxetine 40 MG Delayed Release Oral Capsule | SCD | f5e7503a-b28f-4cd0-a4ee-47bdca88d54b | 1 |
| 616402 | duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule | SY | f5e7503a-b28f-4cd0-a4ee-47bdca88d54b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51991-750-05 | 51991075005 | 500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-750-05) | 2018-05-21 | 0000-00-00 | No | No | Current |
| 51991-750-10 | 51991075010 | 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-750-10) | 2018-05-21 | 0000-00-00 | No | No | Current |
| 51991-750-33 | 51991075033 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-750-33) | 2018-05-21 | 0000-00-00 | No | No | Current |
| 51991-750-90 | 51991075090 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-750-90) | 2018-05-21 | 0000-00-00 | No | No | Current |