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NDC 00338-8701-01 TachoSil 5.5; 2 mg/1; [USP'U]/1 Details
TachoSil 5.5; 2 mg/1; [USP'U]/1
TachoSil is a TOPICAL PATCH in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is FIBRINOGEN HUMAN; HUMAN THROMBIN.
Product Information
| NDC | 00338-8701 |
|---|---|
| Product ID | 0338-8701_da19ff1a-b194-4df8-9a7f-0ca120e15b9a |
| Associated GPIs | 84200025005930 |
| GCN Sequence Number | 066660 |
| GCN Sequence Number Description | fibrinogen/thrombin(human der) ADH. PATCH 9.5X4.8 CM TOPICAL |
| HIC3 | M9A |
| HIC3 Description | TOPICAL HEMOSTATICS |
| GCN | 28986 |
| HICL Sequence Number | 035080 |
| HICL Sequence Number Description | FIBRINOGEN/THROMBIN (HUMAN PLASMA DERIVED) |
| Brand/Generic | Brand |
| Proprietary Name | TachoSil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | THROMBIN HUMAN and FIBRINOGEN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | PATCH |
| Route | TOPICAL |
| Active Ingredient Strength | 5.5; 2 |
| Active Ingredient Units | mg/1; [USP'U]/1 |
| Substance Name | FIBRINOGEN HUMAN; HUMAN THROMBIN |
| Labeler Name | Baxter Healthcare Corporation |
| Pharmaceutical Class | Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125351 |
| Listing Certified Through | n/a |
Package
NDC 00338-8701-01 (00338870101)
| NDC Package Code | 0338-8701-01 |
|---|---|
| Billing NDC | 00338870101 |
| Package | 1 POUCH in 1 CARTON (0338-8701-01) / 1 BLISTER PACK in 1 POUCH (0338-8701-00) / 1 PATCH in 1 BLISTER PACK (0338-8701-99) |
| Marketing Start Date | 2010-04-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |