Omegaven
- Product NDC
- 63323-205
- 11-digit product format
- 633230205
- Labeler code
- 63323
- Product ID
- 63323-205_5cdc585d-835d-4092-850c-12adbcdef9b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fish oil
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA210589
- Marketing category
- NDA
- Marketing start
- 2018-07-27
- Substance
- FISH OIL
- Active strength
- .1 g/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omegaven
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FISH OIL | .1 g/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XGF7L72M0F |
| Rxcui | 2053499, 2053504, 2053513, 2053514 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-205-00 | Omegaven | 10 in 1 CARTON | INJECTION, EMULSION | 10 | | 6 |
| 63323-205-21 | Omegaven | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, EMULSION | 50 | | 6 |
| 63323-205-31 | Omegaven | 100 mL in 1 VIAL, SINGLE-DOSE | INJECTION, EMULSION | 100 | | 6 |
| 63323-205-50 | Omegaven | 10 in 1 CARTON | INJECTION, EMULSION | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-205 | OMEGAVEN (FISH OIL) INJECTION, EMULSION [FRESENIUS KABI USA, LLC
] | 5 | Current NDC, Legacy NDC, 4 package rows | 20230728_5d9d0b24-e139-48bf-ab2d-536fb59cf8e0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-205-00 | 63323020500 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00) / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31) | | 2018-07-27 | 0000-00-00 | No | No | Current |
| 63323-205-21 | 63323020521 | 50 mL in 1 VIAL, SINGLE-DOSE | 50 ml | | | | | Historical |
| 63323-205-31 | 63323020531 | 100 mL in 1 VIAL, SINGLE-DOSE | 100 ml | | | | | Historical |
| 63323-205-50 | 63323020550 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21) | | 2018-07-27 | 0000-00-00 | No | No | Current |