Duloxetine Hydrochloride
- Product NDC
- 60505-2996
- 11-digit product format
- 605052996
- Labeler code
- 60505
- Product ID
- 60505-2996_645ddf53-e91a-09ec-f8a7-6aad7614775d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine Hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA202045
- Marketing category
- ANDA
- Marketing start
- 2014-06-13
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 30 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| aebfdb62-b550-4c4f-9225-d5d3bbc7ab88 | Product name | 9 | 20210727 |
| 7dd29e28-6b69-499b-9257-12a3b46ca283 | Product name | 1 | 20191120 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-2996-3 | EA - Each | 60505-2996 | e46a3b6e-52d5-497a-84be-92146a03a54a | 1 | 2014-07-02 |
| 60505-2996-5 | EA - Each | 60505-2996 | 5b320429-d2f4-4697-8fa6-342ae59cc1d2 | 1 | 2016-09-02 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 596926 | DULoxetine 20 MG Delayed Release Oral Capsule | PSN | 0de8c7fb-1f7c-4466-b7e2-31cd5497211e | 15 |
| 596930 | DULoxetine 30 MG Delayed Release Oral Capsule | PSN | 0de8c7fb-1f7c-4466-b7e2-31cd5497211e | 15 |
| 596934 | DULoxetine 60 MG Delayed Release Oral Capsule | PSN | 0de8c7fb-1f7c-4466-b7e2-31cd5497211e | 15 |
| 596926 | duloxetine 20 MG Delayed Release Oral Capsule | SCD | 0de8c7fb-1f7c-4466-b7e2-31cd5497211e | 15 |
| 596930 | duloxetine 30 MG Delayed Release Oral Capsule | SCD | 0de8c7fb-1f7c-4466-b7e2-31cd5497211e | 15 |
| 596934 | duloxetine 60 MG Delayed Release Oral Capsule | SCD | 0de8c7fb-1f7c-4466-b7e2-31cd5497211e | 15 |
| 596926 | duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule | SY | 0de8c7fb-1f7c-4466-b7e2-31cd5497211e | 15 |
| 596930 | duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule | SY | 0de8c7fb-1f7c-4466-b7e2-31cd5497211e | 15 |
| 596934 | duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule | SY | 0de8c7fb-1f7c-4466-b7e2-31cd5497211e | 15 |
| 596930 | DULoxetine 30 MG Delayed Release Oral Capsule | PSN | 605e149d-d007-44da-a66a-f8f081447807 | 6 |
| 596930 | duloxetine 30 MG Delayed Release Oral Capsule | SCD | 605e149d-d007-44da-a66a-f8f081447807 | 6 |
| 596930 | duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule | SY | 605e149d-d007-44da-a66a-f8f081447807 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60505-2996-3 | 60505299603 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-2996-3) | 2014-06-13 | 0000-00-00 | No | No | Current |
| 60505-2996-5 | 60505299605 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-2996-5) | 2014-06-13 | 0000-00-00 | No | No | Current |
| 60505-2996-6 | 60505299606 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-2996-6) | 2014-06-13 | 0000-00-00 | No | No | Current |
| 60505-2996-8 | 60505299608 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-2996-8) | 2014-06-13 | 0000-00-00 | No | No | Current |