Duloxetine
- Product NDC
- 63629-5202
- 11-digit product format
- 636295202
- Labeler code
- 63629
- Product ID
- 63629-5202_fe3e2db6-1aee-4767-bc1f-8547bac4b41a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090745
- Marketing category
- ANDA
- Marketing start
- 2013-12-11
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 60 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 |
|---|---|---|---|
| aebfdb62-b550-4c4f-9225-d5d3bbc7ab88 | Product name | 9 | 20210727 |
| 7dd29e28-6b69-499b-9257-12a3b46ca283 | Product name | 1 | 20191120 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-5202-1 | Duloxetine | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 1001 | |
| 63629-5202-2 | Duloxetine | 28 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 28 | 1001 | |
| 63629-5202-3 | Duloxetine | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | 1001 | |
| 63629-5202-4 | Duloxetine | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 1001 | |
| 63629-5202-5 | Duloxetine | 180 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 180 | 1001 | |
| 63629-5202-6 | Duloxetine | 120 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 120 | 1001 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-5202-1 | EA - Each | 63629-5202 | ace6d5af-46b4-4762-869b-cb90e7fa8b74 | 1 | 2016-03-04 |
| 63629-5202-2 | EA - Each | 63629-5202 | daaf6303-ac22-488f-be72-a9387ab9100f | 1 | 2016-03-04 |
| 63629-5202-3 | EA - Each | 63629-5202 | df9b988f-6f4c-4170-b3c3-0caa26e14300 | 1 | 2016-03-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-5202 | DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK] | 1001 | Legacy NDC, 6 package rows | 20220217_fe3e2db6-1aee-4767-bc1f-8547bac4b41a.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 596934 | DULoxetine 60 MG Delayed Release Oral Capsule | PSN | fe3e2db6-1aee-4767-bc1f-8547bac4b41a | 1001 |
| 596934 | duloxetine 60 MG Delayed Release Oral Capsule | SCD | fe3e2db6-1aee-4767-bc1f-8547bac4b41a | 1001 |
| 596934 | duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule | SY | fe3e2db6-1aee-4767-bc1f-8547bac4b41a | 1001 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-5202-1 | 63629520201 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5202-1) | 2014-01-20 | 0000-00-00 | No | No | Current |
| 63629-5202-2 | 63629520202 | 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5202-2) | 2014-01-09 | 0000-00-00 | No | No | Current |
| 63629-5202-3 | 63629520203 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5202-3) | 2014-02-21 | 0000-00-00 | No | No | Current |
| 63629-5202-4 | 63629520204 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5202-4) | 2015-08-10 | 0000-00-00 | No | No | Current |
| 63629-5202-5 | 63629520205 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5202-5) | 2022-02-08 | 0000-00-00 | No | No | Current |
| 63629-5202-6 | 63629520206 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5202-6) | 2022-02-08 | 0000-00-00 | No | No | Current |