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NDC 63323-0820-10 Smoflipid 3; 6; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL Details
Smoflipid 3; 6; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL
Smoflipid is a INTRAVENOUS INJECTION, EMULSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is FISH OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL.
Product Information
| NDC | 63323-0820 |
|---|---|
| Product ID | 63323-820_7b8a6525-3481-465a-86b9-e92ef38cec75 |
| Associated GPIs | 80200010101620 |
| GCN Sequence Number | 066507 |
| GCN Sequence Number Description | fat emul/soy/mct/oliv/fish oil EMULSION 20 % INTRAVEN |
| HIC3 | M4B |
| HIC3 Description | IV FAT EMULSIONS |
| GCN | 28797 |
| HICL Sequence Number | 037062 |
| HICL Sequence Number Description | FAT EMULSIONS/SOYBEAN OIL/MED CHAIN TRIGL/OLIVE OIL/FISH OIL |
| Brand/Generic | Brand |
| Proprietary Name | Smoflipid |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Smoflipid |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, EMULSION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 3; 6; 5; 6 |
| Active Ingredient Units | g/100mL; g/100mL; g/100mL; g/100mL |
| Substance Name | FISH OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA207648 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0820-10 (63323082010)
| NDC Package Code | 63323-820-10 |
|---|---|
| Billing NDC | 63323082010 |
| Package | 6 BAG in 1 CASE (63323-820-10) / 1000 mL in 1 BAG (63323-820-05) |
| Marketing Start Date | 2019-05-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |