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NDC 53002-1561-03 Duloxetine 60 mg/1 Details
Duloxetine 60 mg/1
Duloxetine is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is DULOXETINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Duloxetine is used to treat depression in adults and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life and lasts for 6 months or longer) in adults and children 7 years of age and older. Duloxetine is also used to treat pain and tingling caused by diabetic neuropathy (damage to nerves that can develop in people who have diabetes) in adults and fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep) in adults and children 13 years of age and older. It is also used to treat ongoing bone or muscle pain such as lower back pain or osteoarthritis (joint pain or stiffness that may worsen over time) in adults. Duloxetine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amounts of serotonin and norepinephrine, natural substances in the brain that help maintain mental balance and stop the movement of pain signals in the brain.
Related Packages: 53002-1561-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Duloxetine
Product Information
| NDC | 53002-1561 |
|---|---|
| Product ID | 53002-1561_b7aa41c1-dd45-49ec-b046-c44493c2faa0 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Duloxetine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Duloxetine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 60 |
| Active Ingredient Units | mg/1 |
| Substance Name | DULOXETINE HYDROCHLORIDE |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Pharmaceutical Class | Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208706 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53002-1561-03 (53002156103)
| NDC Package Code | 53002-1561-3 |
|---|---|
| Billing NDC | 53002156103 |
| Package | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53002-1561-3) |
| Marketing Start Date | 2017-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |