Duloxetine Hydrochloride
- Product NDC
- 50436-2997
- 11-digit product format
- 504362997
- Labeler code
- 50436
- Product ID
- 50436-2997_f608aaaa-a739-42fd-8d75-ee786ba3fdbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine Hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA202045
- Marketing category
- ANDA
- Marketing start
- 2014-06-13
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-2997-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-57ab-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval: 2004 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-2997-1 | Duloxetine Hydrochloride | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-2997-1 | EA - Each | 50436-2997 | 48fe283a-3740-41b1-a6ca-45a8894b9d1e | 1 | 2017-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-2997 | DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE ) CAPSULE, DELAYED RELEASE DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE ) CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 15 | Legacy NDC, 1 package rows | 20190212_0de8c7fb-1f7c-4466-b7e2-31cd5497211e.zip |
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 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-2997-1 | 50436299701 | 30 in 1 BOTTLE | Historical |