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NDC 00093-3066-34 Icatibant 10 mg/mL Details
Icatibant 10 mg/mL
Icatibant is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Teva Pharmaceuticals USA, Inc.. The primary component is ICATIBANT ACETATE.
Product Information
| NDC | 00093-3066 |
|---|---|
| Product ID | 0093-3066_ea64720c-2b46-4ff1-9231-3f2b20968fcd |
| Associated GPIs | 85820040102020 |
| GCN Sequence Number | 064564 |
| GCN Sequence Number Description | icatibant acetate SYRINGE 30 MG/3 ML SUBCUT |
| HIC3 | A7M |
| HIC3 Description | BRADYKININ B2 RECEPTOR ANTAGONISTS |
| GCN | 14778 |
| HICL Sequence Number | 035962 |
| HICL Sequence Number Description | ICATIBANT ACETATE |
| Brand/Generic | Generic |
| Proprietary Name | Icatibant |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Icatibant |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | ICATIBANT ACETATE |
| Labeler Name | Teva Pharmaceuticals USA, Inc. |
| Pharmaceutical Class | Bradykinin B2 Receptor Antagonist [EPC], Bradykinin B2 Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210118 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00093-3066-34 (00093306634)
| NDC Package Code | 0093-3066-34 |
|---|---|
| Billing NDC | 00093306634 |
| Package | 1 SYRINGE in 1 CARTON (0093-3066-34) / 3 mL in 1 SYRINGE |
| Marketing Start Date | 2019-07-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |