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NDC 60505-6214-01 ICATIBANT 30 mg/3mL Details
ICATIBANT 30 mg/3mL
ICATIBANT is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is ICATIBANT ACETATE.
Product Information
| NDC | 60505-6214 |
|---|---|
| Product ID | 60505-6214_5d2a3299-fbbf-4d00-ad37-13a5fcc632f6 |
| 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 acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/3mL |
| Substance Name | ICATIBANT ACETATE |
| Labeler Name | Apotex Corp. |
| Pharmaceutical Class | Bradykinin B2 Receptor Antagonist [EPC], Bradykinin B2 Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212081 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 60505-6214-01 (60505621401)
| NDC Package Code | 60505-6214-1 |
|---|---|
| Billing NDC | 60505621401 |
| Package | 1 SYRINGE, GLASS in 1 CARTON (60505-6214-1) / 3 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2021-04-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |