Ibuprofen is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Ibuprofen.
| Product ID | 70518-0761_7617c5ad-f7fe-8ece-e053-2991aa0ad8b2 |
| NDC | 70518-0761 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ibuprofen |
| Generic Name | Ibuprofen |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-10-06 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091625 |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | IBUPROFEN |
| Active Ingredient Strength | 600 mg/1 |
| Pharm Classes | Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2017-10-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091625 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-06 |
| Marketing Category | ANDA |
| Application Number | ANDA091625 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-09-17 |
| Marketing Category | ANDA |
| Application Number | ANDA091625 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-07-27 |
| Marketing Category | ANDA |
| Application Number | ANDA091625 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-09 |
| Marketing Category | ANDA |
| Application Number | ANDA091625 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-06 |
| Marketing Category | ANDA |
| Application Number | ANDA091625 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-07-26 |
| Marketing Category | ANDA |
| Application Number | ANDA091625 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-07-30 |
| Marketing Category | ANDA |
| Application Number | ANDA091625 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-10-16 |
| Ingredient | Strength |
|---|---|
| IBUPROFEN | 600 mg/1 |
| SPL SET ID: | 1e6f3ce7-e8a3-40e8-8437-523ef5277b2e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| PHarm Class EPC | |
| NUI Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 67877-120 | ibuprofen | ibuprofen |
| 67877-119 | ibuprofen | ibuprofen |
| 67877-295 | ibuprofen | ibuprofen |
| 67877-121 | ibuprofen | ibuprofen |
| 67877-294 | ibuprofen | ibuprofen |
| 67877-296 | ibuprofen | ibuprofen |
| 67877-321 | Ibuprofen | Ibuprofen |
| 67877-319 | Ibuprofen | Ibuprofen |
| 67877-320 | Ibuprofen | Ibuprofen |
| 68016-116 | Ibuprofen | Ibuprofen |
| 68016-633 | Ibuprofen | Ibuprofen |
| 68016-626 | Ibuprofen | Ibuprofen |
| 68016-634 | Ibuprofen | Ibuprofen |
| 68016-645 | Ibuprofen | Ibuprofen |
| 68016-295 | Ibuprofen | Ibuprofen |
| 68016-635 | Ibuprofen | Ibuprofen |
| 68071-3074 | Ibuprofen | Ibuprofen |
| 68071-3362 | IBUPROFEN | IBUPROFEN |
| 68071-4129 | Ibuprofen | Ibuprofen |
| 68071-4009 | IBUPROFEN | IBUPROFEN |
| 68071-3388 | Ibuprofen | Ibuprofen |
| 68071-4253 | Ibuprofen | Ibuprofen |
| 68071-4306 | Ibuprofen | Ibuprofen |
| 68071-4357 | Ibuprofen | Ibuprofen |
| 68071-4563 | Ibuprofen | Ibuprofen |
| 68071-4280 | Ibuprofen | Ibuprofen |
| 68071-4243 | IBUPROFEN | IBUPROFEN |
| 68071-4820 | Ibuprofen | Ibuprofen |
| 68071-4305 | Ibuprofen | Ibuprofen |
| 68071-4459 | IBUPROFEN | IBUPROFEN |
| 68084-703 | Ibuprofen | Ibuprofen |
| 68084-658 | Ibuprofen | Ibuprofen |
| 68084-772 | Ibuprofen | Ibuprofen |
| 68196-980 | Ibuprofen | Ibuprofen |
| 68196-981 | Ibuprofen | Ibuprofen |
| 68210-0200 | IBUPROFEN | IBUPROFEN |
| 68196-199 | Ibuprofen | Ibuprofen |
| 68210-0009 | IBUPROFEN | IBUPROFEN |
| 68196-745 | Ibuprofen | Ibuprofen |
| 68387-208 | Ibuprofen | Ibuprofen |
| 0472-2002 | Ibuprofen | Ibuprofen |
| 68387-210 | Ibuprofen | Ibuprofen |
| 68391-121 | Ibuprofen | Ibuprofen |
| 68391-199 | Ibuprofen | Ibuprofen |
| 0472-1270 | Ibuprofen | Ibuprofen |
| 68645-531 | Ibuprofen | Ibuprofen |
| 68645-563 | Ibuprofen | Ibuprofen |
| 68645-562 | Ibuprofen | Ibuprofen |
| 68645-561 | Ibuprofen | Ibuprofen |
| 0113-1461 | basic care childrens ibuprofen | Ibuprofen |