NAPROXEN SODIUM is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Spirit Pharmaceuticals,llc. The primary component is Naproxen Sodium.
| Product ID | 68210-0040_60dee681-fc0c-32cf-e053-2a91aa0a44f3 |
| NDC | 68210-0040 |
| Product Type | Human Otc Drug |
| Proprietary Name | NAPROXEN SODIUM |
| Generic Name | Naproxen Sodium |
| Dosage Form | Tablet, Film Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-12-22 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091353 |
| Labeler Name | SPIRIT PHARMACEUTICALS,LLC |
| Substance Name | NAPROXEN SODIUM |
| Active Ingredient Strength | 220 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2017-12-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091353 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-12-22 |
| Marketing Category | ANDA |
| Application Number | ANDA091353 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-04-06 |
| Ingredient | Strength |
|---|---|
| NAPROXEN SODIUM | 220 mg/1 |
| SPL SET ID: | fbb27242-8ec6-453f-b2f1-de0b28492c57 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68016-056 | Naproxen Sodium | Naproxen Sodium |
| 68016-661 | Naproxen Sodium | Naproxen Sodium |
| 68016-660 | Naproxen Sodium | Naproxen Sodium |
| 68071-3054 | Naproxen Sodium | Naproxen Sodium |
| 68071-3223 | Naproxen Sodium | Naproxen Sodium |
| 68210-0040 | NAPROXEN SODIUM | NAPROXEN SODIUM |
| 68210-0400 | NAPROXEN SODIUM | NAPROXEN SODIUM |
| 68387-545 | Naproxen Sodium | Naproxen Sodium |
| 68462-179 | Naproxen Sodium | Naproxen Sodium |
| 68462-178 | Naproxen Sodium | Naproxen Sodium |
| 68788-6406 | Naproxen Sodium | Naproxen Sodium |
| 68788-7304 | Naproxen Sodium | Naproxen Sodium |
| 68788-6934 | Naproxen Sodium | Naproxen Sodium |
| 68788-7367 | Naproxen Sodium | Naproxen Sodium |
| 68788-9022 | Naproxen Sodium | Naproxen Sodium |
| 68998-144 | NAPROXEN SODIUM | NAPROXEN SODIUM |
| 68998-145 | NAPROXEN SODIUM | NAPROXEN SODIUM |
| 69168-632 | Naproxen Sodium | Naproxen Sodium |
| 69230-305 | Naproxen Sodium | Naproxen Sodium |
| 69452-179 | Naproxen Sodium | Naproxen Sodium |
| 69469-169 | Naproxen Sodium | Naproxen Sodium |
| 69842-010 | naproxen sodium | naproxen sodium |
| 69842-748 | Naproxen Sodium | Naproxen Sodium |
| 69842-417 | Naproxen Sodium | Naproxen Sodium |
| 69842-975 | Naproxen Sodium | Naproxen Sodium |
| 69842-811 | Naproxen Sodium | Naproxen Sodium |
| 70518-0409 | Naproxen Sodium | Naproxen Sodium |
| 70518-0178 | Naproxen sodium | Naproxen sodium |
| 70518-0724 | Naproxen Sodium | Naproxen Sodium |
| 70518-1172 | Naproxen Sodium | Naproxen Sodium |
| 71141-116 | NAPROXEN SODIUM | NAPROXEN SODIUM |
| 71141-008 | Naproxen Sodium | Naproxen Sodium |
| 71335-0274 | Naproxen Sodium | Naproxen Sodium |
| 71335-0822 | Naproxen Sodium | Naproxen Sodium |
| 71335-1061 | Naproxen Sodium | Naproxen Sodium |
| 10544-275 | Naproxen Sodium | Naproxen Sodium |
| 10544-128 | Naproxen Sodium | Naproxen Sodium |
| 10544-063 | Naproxen Sodium | Naproxen Sodium |
| 10544-276 | Naproxen Sodium | Naproxen Sodium |
| 11673-175 | Naproxen Sodium | Naproxen Sodium |
| 11822-0507 | naproxen sodium | naproxen sodium |
| 11673-748 | Naproxen Sodium | Naproxen Sodium |
| 11822-0490 | naproxen sodium | naproxen sodium |
| 11822-0140 | Naproxen Sodium | Naproxen Sodium |
| 21130-174 | Naproxen Sodium | Naproxen Sodium |
| 21130-748 | Naproxen Sodium | Naproxen Sodium |
| 21695-090 | Naproxen Sodium | Naproxen Sodium |
| 17856-0194 | Naproxen Sodium | Naproxen Sodium |
| 25000-141 | Naproxen Sodium | Naproxen Sodium |
| 25000-144 | Naproxen Sodium | Naproxen Sodium |