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NDC 63323-0205-00 Omegaven 0.1 g/mL Details
Omegaven 0.1 g/mL
Omegaven 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.
Product Information
| NDC | 63323-0205 |
|---|---|
| Product ID | 63323-205_10a23baf-3b3c-4dad-96c9-804804b3f70b |
| Associated GPIs | 80200010051630 80200010051620 |
| GCN Sequence Number | 062134 |
| GCN Sequence Number Description | fatty acid6/fish oil/gly/p-lip EMULSION 10 % INTRAVEN |
| HIC3 | M4B |
| HIC3 Description | IV FAT EMULSIONS |
| GCN | 97919 |
| HICL Sequence Number | 034407 |
| HICL Sequence Number Description | FATTY ACIDS COMBO. NO.6/FISH OIL/GLYCERIN/PHOSPHOLIPIDS, EGG |
| Brand/Generic | Brand |
| Proprietary Name | Omegaven |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fish oil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, EMULSION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 0.1 |
| Active Ingredient Units | g/mL |
| Substance Name | FISH OIL |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA210589 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0205-00 (63323020500)
| NDC Package Code | 63323-205-00 |
|---|---|
| Billing NDC | 63323020500 |
| Package | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00) / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31) |
| Marketing Start Date | 2018-07-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |