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NDC 61919-0608-60 DICLOFENAC SODIUM 100 mg/1 Details
DICLOFENAC SODIUM 100 mg/1
DICLOFENAC SODIUM is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by DIRECTRX. The primary component is DICLOFENAC SODIUM.
MedlinePlus Drug Summary
Diclofenac capsules (Zipsor, Zorvolex) and tablets (Cataflam) are used to relieve mild to moderate pain. Diclofenac extended-release tablets (Voltaren XR), tablets (Cataflam), and delayed-release tablets (available generically) are used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Diclofenac extended-release tablets and delayed-release tablets are also used to treat ankylosing spondylitis (arthritis that mainly affects the spine). Diclofenac tablets (Cataflam) are also used to treat painful menstrual periods. Diclofenac solution (Cambia) is used to treat migraine headaches in adults, but cannot be used to prevent migraines or to treat other types of headaches. Diclofenac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 61919-0608-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diclofenac
Product Information
| NDC | 61919-0608 |
|---|---|
| Product ID | 61919-608_fb4797df-5f1e-4954-e053-6294a90ad657 |
| Associated GPIs | 66100007207530 |
| GCN Sequence Number | 011933 |
| GCN Sequence Number Description | diclofenac sodium TAB ER 24H 100 MG ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 13310 |
| HICL Sequence Number | 003733 |
| HICL Sequence Number Description | DICLOFENAC SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | DICLOFENAC SODIUM |
| Proprietary Name Suffix | E/R |
| Non-Proprietary Name | DICLOFENAC SODIUM |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | DICLOFENAC SODIUM |
| Labeler Name | DIRECTRX |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075492 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 61919-0608-60 (61919060860)
| NDC Package Code | 61919-608-60 |
|---|---|
| Billing NDC | 61919060860 |
| Package | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-608-60) |
| Marketing Start Date | 2019-04-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |