CEFDINIR is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Cefdinir Monohydrate.
| Product ID | 76519-1172_7640dd80-1a57-9805-e053-2991aa0acbb5 |
| NDC | 76519-1172 |
| Product Type | Human Prescription Drug |
| Proprietary Name | CEFDINIR |
| Generic Name | Cefdinir |
| Dosage Form | Powder, For Suspension |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-03-26 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA065332 |
| Labeler Name | H.J. Harkins Company, Inc. |
| Substance Name | CEFDINIR MONOHYDRATE |
| Active Ingredient Strength | 125 mg/5mL |
| Pharm Classes | Cephalosporin Antibacterial [EPC],Cephalosporins [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-03-26 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA065332 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-03-26 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| CEFDINIR MONOHYDRATE | 125 mg/5mL |
| SPL SET ID: | 7640dd80-1a56-9805-e053-2991aa0acbb5 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-3160 | Cefdinir | Cefdinir |
| 0093-4136 | Cefdinir | Cefdinir |
| 0093-4137 | Cefdinir | Cefdinir |
| 0781-2176 | Cefdinir | Cefdinir |
| 0781-6077 | Cefdinir | Cefdinir |
| 0781-6078 | Cefdinir | Cefdinir |
| 10544-194 | Cefdinir | Cefdinir |
| 16714-391 | Cefdinir | Cefdinir |
| 16714-392 | Cefdinir | Cefdinir |
| 16714-393 | Cefdinir | Cefdinir |
| 17856-1150 | Cefdinir | Cefdinir |
| 21695-620 | Cefdinir | Cefdinir |
| 21695-622 | Cefdinir | Cefdinir |
| 33261-905 | Cefdinir | Cefdinir |
| 42043-250 | Cefdinir | Cefdinir |
| 42043-251 | Cefdinir | Cefdinir |
| 42043-252 | Cefdinir | Cefdinir |
| 42254-127 | Cefdinir | Cefdinir |
| 42254-177 | Cefdinir | Cefdinir |
| 43063-466 | Cefdinir | Cefdinir |
| 43063-597 | Cefdinir | Cefdinir |
| 43063-852 | Cefdinir | Cefdinir |
| 43063-853 | Cefdinir | Cefdinir |
| 43063-959 | Cefdinir | Cefdinir |
| 68001-150 | Cefdinir | Cefdinir |
| 68001-362 | Cefdinir | Cefdinir |
| 68071-1788 | Cefdinir | Cefdinir |
| 68071-3156 | Cefdinir | Cefdinir |
| 68071-4007 | Cefdinir | Cefdinir |
| 68071-3032 | Cefdinir | Cefdinir |
| 68071-3393 | Cefdinir | Cefdinir |
| 68071-4236 | Cefdinir | Cefdinir |
| 68071-3295 | Cefdinir | Cefdinir |
| 68071-4419 | Cefdinir | Cefdinir |
| 68071-4792 | Cefdinir | Cefdinir |
| 68180-723 | Cefdinir | Cefdinir |
| 68258-3053 | Cefdinir | Cefdinir |
| 68180-711 | Cefdinir | Cefdinir |
| 68180-722 | Cefdinir | Cefdinir |
| 68788-6840 | Cefdinir | Cefdinir |
| 68788-7062 | Cefdinir | Cefdinir |
| 68788-7111 | Cefdinir | Cefdinir |
| 68788-7255 | Cefdinir | Cefdinir |
| 68788-7339 | Cefdinir | Cefdinir |
| 68788-7375 | Cefdinir | Cefdinir |
| 68788-9760 | Cefdinir | Cefdinir |
| 70518-1213 | Cefdinir | Cefdinir |
| 70934-062 | Cefdinir | Cefdinir |
| 70934-164 | Cefdinir | Cefdinir |
| 70934-044 | Cefdinir | Cefdinir |