IBUPROFEN AND DIPHENHYDRAMINE HCL is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is Diphenhydramine Hydrochloride; Ibuprofen.
| Product ID | 64380-732_2c462426-b635-44dd-b4cb-54f67afb37d9 |
| NDC | 64380-732 |
| Product Type | Human Otc Drug |
| Proprietary Name | IBUPROFEN AND DIPHENHYDRAMINE HCL |
| Generic Name | Ibuprofen And Diphenhydramine Hcl |
| Dosage Form | Capsule, Liquid Filled |
| Route of Administration | ORAL |
| Marketing Start Date | 2012-03-05 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA200888 |
| Labeler Name | Strides Pharma Science Limited |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN |
| Active Ingredient Strength | 25 mg/1; mg/1 |
| Pharm Classes | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2016-12-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA200888 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-12-28 |
| Marketing Category | ANDA |
| Application Number | ANDA200888 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-03-05 |
| Marketing Category | ANDA |
| Application Number | ANDA200888 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-12-28 |
| Marketing Category | ANDA |
| Application Number | ANDA200888 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-12-28 |
| Marketing Category | ANDA |
| Application Number | ANDA200888 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-03-05 |
| Marketing Category | ANDA |
| Application Number | ANDA200888 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-12-28 |
| Marketing Category | ANDA |
| Application Number | ANDA200888 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-03-05 |
| Marketing Category | ANDA |
| Application Number | ANDA200888 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-11-21 |
| Marketing Category | ANDA |
| Application Number | ANDA200888 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-12-28 |
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| SPL SET ID: | 10d52858-a55f-4053-aa77-da660556a2ad |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| PHarm Class EPC | |
| UPC Code | |
| NUI Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0363-0665 | Ibuprofen and Diphenhydramine HCl | IBUPROFEN, DIPHENHYDRAMINE HCL |
| 49035-065 | Ibuprofen and Diphenhydramine HCl | IBUPROFEN, DIPHENHYDRAMINE HCL |
| 49035-858 | Ibuprofen and Diphenhydramine HCl | IBUPROFEN, DIPHENHYDRAMINE HCL |
| 59726-165 | Ibuprofen and Diphenhydramine HCl | IBUPROFEN, DIPHENHYDRAMINE HCL |
| 64380-732 | IBUPROFEN AND DIPHENHYDRAMINE HCL | IBUPROFEN AND DIPHENHYDRAMINE HCL |
| 68016-217 | Ibuprofen and Diphenhydramine HCl | IBUPROFEN, DIPHENHYDRAMINE HCL |
| 36800-165 | Ibuprofen PM | Ibuprofen and Diphenhydramine HCl |
| 50804-165 | Ibuprofen PM | Ibuprofen and Diphenhydramine HCl |
| 50844-732 | Ibuprofen PM | Ibuprofen and Diphenhydramine HCl |
| 55315-165 | Ibuprofen PM | Ibuprofen and Diphenhydramine HCl |
| 63941-166 | Ibuprofen PM | Ibuprofen and Diphenhydramine HCl |