Nudroxipak DSDR-75
Name: Nudroxipak DSDR-75
Nudroxipak DSDR-75 Description
Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium, USP is a white to almost white crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula
Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide.
Indications and Usage for Nudroxipak DSDR-75
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation) .
Diclofenac sodium delayed-release tablets, USP are indicated:
- For relief of the signs and symptoms of osteoarthritis
- For relief of the signs and symptoms of rheumatoid arthritis
- For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
How supplied
Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:
75 mg Each white, round, enteric-coated tablet printed with on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 0228-2551-06)
Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP.
Manufactured by:
Actavis Elizabeth LLC
Elizabeth, NJ 07207 USA
Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
40-9184
Revised October 2017
Do not use
On cuts or infected skin, on children less than 12 years old in large amount.
NDC 70859-028-03 NuDroxicin Pain Relief Roll-On
Nudroxipak DSDR-75 Diclofenac Sod DR 75mg
Nudroxipak DSDR-75
diclofenac sodium, methyl salicylate/menthol/capsaicin kit |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:70859-034 | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:70859-034-01 | 1 KIT in 1 CARTON | |
| Quantity of Parts | | Part # | Package Quantity | Total Product Quantity | | Part 1 | 1 BOTTLE | 60 | | Part 2 | 1 CONTAINER | 90 mL | |
| Part 1 of 2 | DICLOFENAC SODIUM
diclofenac sodium tablet, delayed release | |
| Product Information | | Item Code (Source) | NDC:0228-2551 | | Route of Administration | ORAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | DICLOFENAC SODIUM (DICLOFENAC) | DICLOFENAC SODIUM | 75 mg | |
| Inactive Ingredients | | Ingredient Name | Strength | | SODIUM ALGINATE | | | ALUMINUM HYDROXIDE | | | POLYSORBATE 80 | | | SODIUM STARCH GLYCOLATE TYPE A POTATO | | | STEARIC ACID | | | FERROSOFERRIC OXIDE | | | TALC | | | TITANIUM DIOXIDE | | | POLYVINYL ACETATE PHTHALATE | | | HYPROMELLOSE, UNSPECIFIED | | | LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE) | | | MAGNESIUM STEARATE | | | POLYETHYLENE GLYCOL, UNSPECIFIED | | | PROPYLENE GLYCOL | | | SILICON DIOXIDE | | | MICROCRYSTALLINE CELLULOSE | | |
| Product Characteristics | | Color | white | Score | no score | | Shape | ROUND | Size | 9mm | | Flavor | | Imprint Code | R;551 | | Contains | | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0228-2551-06 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | ANDA | ANDA074514 | 03/26/1996 | | |
| Part 2 of 2 | NUDROXICIN PAIN RELIEF ROLL-ON
methyl salicylate, menthol, capsaicin liquid | |
| Product Information | | Item Code (Source) | NDC:70859-028 | | Route of Administration | TOPICAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | MENTHOL (MENTHOL) | MENTHOL | 60 mg in 1 mL | | CAPSAICIN (CAPSAICIN) | CAPSAICIN | 0.25 mg in 1 mL | | METHYL SALICYLATE (SALICYLIC ACID) | METHYL SALICYLATE | 250 mg in 1 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | MAGNESIUM SULFATE, UNSPECIFIED FORM | | | DIMETHYL SULFONE | | | INDIAN FRANKINCENSE | | | WATER | | | ARNICA MONTANA FLOWER | | | YELLOW WAX | | | CARBOXYPOLYMETHYLENE | | | CETEARYL OLIVATE | | | ETHYLHEXYLGLYCERIN | | | GLYCERYL MONOSTEARATE | | | ILEX PARAGUARIENSIS LEAF | | | SORBITAN OLIVATE | | | POLYSORBATE 20 | | | PHENOXYETHANOL | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:70859-028-03 | 1 CONTAINER in 1 CARTON | | 1 | | 90 mL in 1 CONTAINER | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | OTC monograph not final | part348 | 02/07/2018 | | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | ANDA | ANDA074514 | 03/16/2018 | | |
| Labeler - NuCare Pharmaceuticals,Inc. (010632300) |
| Establishment |
| Name | Address | ID/FEI | Operations |
| NuCare Pharmceuticals,Inc. | | 010632300 | manufacture(70859-034) |
Revised: 03/2018 NuCare Pharmaceuticals,Inc.
