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NDC 70720-0722-10 PRIALT 100 ug/mL Details
PRIALT 100 ug/mL
PRIALT is a INTRATHECAL INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by TerSera Therapeutics LLC. The primary component is ZICONOTIDE ACETATE.
Product Information
| NDC | 70720-0722 |
|---|---|
| Product ID | 70720-722_e54fb2ff-1fa1-479d-8ec4-3eafc5c1920e |
| Associated GPIs | 64154090102030 |
| GCN Sequence Number | 058584 |
| GCN Sequence Number Description | ziconotide acetate VIAL 100 MCG/ML INTRATHEC |
| HIC3 | H3I |
| HIC3 Description | ANALGESICS, NEURONAL-TYPE CALCIUM CHANNEL BLOCKERS |
| GCN | 24052 |
| HICL Sequence Number | 026826 |
| HICL Sequence Number Description | ZICONOTIDE ACETATE |
| Brand/Generic | Brand |
| Proprietary Name | PRIALT |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ziconotide acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRATHECAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | ug/mL |
| Substance Name | ZICONOTIDE ACETATE |
| Labeler Name | TerSera Therapeutics LLC |
| Pharmaceutical Class | N-Calcium Channel Receptor Antagonists [MoA], N-type Calcium Channel Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021060 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70720-0722-10 (70720072210)
| NDC Package Code | 70720-722-10 |
|---|---|
| Billing NDC | 70720072210 |
| Package | 1 VIAL, GLASS in 1 CARTON (70720-722-10) / 5 mL in 1 VIAL, GLASS |
| Marketing Start Date | 2019-08-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |