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NDC 65219-0295-10 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 | 65219-0295 |
|---|---|
| Product ID | 65219-295_499d7fa7-43ab-47f0-ae4b-0f9791745f14 |
| 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 | ANDA216904 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65219-0295-10 (65219029510)
| NDC Package Code | 65219-295-10 |
|---|---|
| Billing NDC | 65219029510 |
| Package | 1 VIAL, MULTI-DOSE in 1 CARTON (65219-295-10) / 10 mL in 1 VIAL, MULTI-DOSE |
| Marketing Start Date | 2023-09-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |