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NDC 63323-0579-05 SINCALIDE 5 ug/5mL Details
SINCALIDE 5 ug/5mL
SINCALIDE is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is SINCALIDE.
Product Information
| NDC | 63323-0579 |
|---|---|
| Product ID | 63323-579_efc423ee-f932-45d4-9fd2-d4b4c350f5db |
| Associated GPIs | |
| GCN Sequence Number | 003097 |
| GCN Sequence Number Description | sincalide VIAL 5 MCG INJECTION |
| HIC3 | D7B |
| HIC3 Description | CHOLERETICS |
| GCN | 09830 |
| HICL Sequence Number | 001372 |
| HICL Sequence Number Description | SINCALIDE |
| Brand/Generic | Generic |
| Proprietary Name | SINCALIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sincalide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | ug/5mL |
| Substance Name | SINCALIDE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Cholecystokinin Analog [EPC], Cholecystokinin [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA017697 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0579-05 (63323057905)
| NDC Package Code | 63323-579-05 |
|---|---|
| Billing NDC | 63323057905 |
| Package | 10 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01) |
| Marketing Start Date | 2023-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |