IBU is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Ibuprofen.
| Product ID | 53002-3370_40ff6c9d-1764-44a9-a2fe-b170ab4f6d23 |
| NDC | 53002-3370 |
| Product Type | Human Prescription Drug |
| Proprietary Name | IBU |
| Generic Name | Ibuprofen |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2008-11-20 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA075682 |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Substance Name | IBUPROFEN |
| Active Ingredient Strength | 400 mg/1 |
| Pharm Classes | Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2017-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA075682 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-01 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-19 |
| Marketing Category | ANDA |
| Application Number | ANDA075682 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-01 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-19 |
| Marketing Category | ANDA |
| Application Number | ANDA075682 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-01 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-19 |
| Ingredient | Strength |
|---|---|
| IBUPROFEN | 400 mg/1 |
| SPL SET ID: | e25dd2e8-a1d4-4098-9b8a-c20a635969d4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| PHarm Class EPC | |
| NUI Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68071-1827 | IBU | IBU |
| 68071-3053 | IBU | IBU |
| 68071-3125 | IBU | IBU |
| 68071-3172 | IBU | IBU |
| 70518-0490 | IBU | IBU |
| 70518-1145 | IBU | IBU |
| 10544-071 | IBU | IBU |
| 10544-625 | IBU | IBU |
| 35356-699 | IBU | IBU |
| 43353-273 | IBU | IBU |
| 49999-042 | IBU | IBU |
| 50436-0684 | IBU | IBU |
| 50436-4605 | IBU | IBU |
| 50436-4604 | IBU | IBU |
| 53002-3370 | IBU | IBU |
| 53002-3980 | IBU | IBU |
| 53002-3010 | IBU | IBU |
| 53217-366 | IBU | IBU |
| 55111-683 | IBU | IBU |
| 55111-684 | IBU | IBU |
| 55111-682 | IBU | IBU |
| 60429-219 | IBU | IBU |
| 60429-220 | IBU | IBU |
| 60429-221 | IBU | IBU |
| 60760-135 | IBU | IBU |
| 60760-076 | IBU | IBU |
| 61919-621 | IBU | IBU |
| 63187-614 | IBU | IBU |
| 66267-116 | IBU | IBU |
| 66267-117 | IBU | IBU |
| 66267-963 | IBU | IBU |
| 66267-793 | IBU | IBU |
| 66267-795 | IBU | IBU |
| 66267-964 | IBU | IBU |
| 66267-794 | IBU | IBU |
| 67296-1217 | IBU | IBU |
| 67296-0877 | IBU | IBU |
| 67296-0913 | IBU | IBU |
| 70934-195 | IBU | IBU |
| 71610-275 | IBU | IBU |
| 0615-8116 | IBU | IBU |
| 0615-8115 | IBU | IBU |
| 0615-8117 | IBU | IBU |
| 50090-4341 | IBU | IBU |
| 50090-4333 | IBU | IBU |
| 0113-1461 | basic care childrens ibuprofen | Ibuprofen |
| 0113-7619 | basic care childrens ibuprofen | ibuprofen |
| 0113-7660 | basic care childrens ibuprofen | Ibuprofen |
| 0113-7897 | Basic Care childrens ibuprofen | Ibuprofen |
| 0113-0788 | Basic Care ibuprofen | Ibuprofen |