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
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 Identifiers#
| Field | Values |
|---|---|
| Unii | 9044SC542W |
| Rxcui | 596926, 596930, 596934, 616402 |
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 |
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 |