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NDC 65219-0293-01 Desmopressin Acetate 4 ug/mL Details
Desmopressin Acetate 4 ug/mL
Desmopressin Acetate is a INTRAVENOUS; SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is DESMOPRESSIN ACETATE.
Product Information
| NDC | 65219-0293 |
|---|---|
| Product ID | 65219-293_8c4f989c-e7b2-428d-8b5f-3a77c0583bd5 |
| Associated GPIs | |
| GCN Sequence Number | 006616 |
| GCN Sequence Number Description | desmopressin acetate VIAL 4 MCG/ML INJECTION |
| HIC3 | P2B |
| HIC3 Description | ANTIDIURETIC AND VASOPRESSOR HORMONES |
| GCN | 10260 |
| HICL Sequence Number | 002841 |
| HICL Sequence Number Description | DESMOPRESSIN ACETATE |
| Brand/Generic | Generic |
| Proprietary Name | Desmopressin Acetate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Desmopressin Acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS; SUBCUTANEOUS |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | ug/mL |
| Substance Name | DESMOPRESSIN ACETATE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA216922 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65219-0293-01 (65219029301)
| NDC Package Code | 65219-293-01 |
|---|---|
| Billing NDC | 65219029301 |
| Package | 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-293-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-293-00) |
| Marketing Start Date | 2023-09-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |