omega-3-acid ethyl esters
- Product NDC
- 64380-761
- 11-digit product format
- 643800761
- Labeler code
- 64380
- Product ID
- 64380-761_8d39d714-db8f-4d90-90c7-ee249eb17de9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omega-3-acid ethyl esters
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA203893
- Marketing category
- ANDA
- Marketing start
- 2019-01-18
- Marketing end
- 0000-00-00
- Substance
- OMEGA-3-ACID ETHYL ESTERS
- Active strength
- 900 mg/1
- Pharmacologic classes
- Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- omega-3-acid ethyl esters
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEGA-3-ACID ETHYL ESTERS | 900 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D87YGH4Z0Q |
| Rxcui | 577208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-761-01 | omega-3-acid ethyl esters | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 7 |
| 64380-761-02 | omega-3-acid ethyl esters | 5 in 1 CARTON | CAPSULE | 5 | | 7 |
| 64380-761-11 | omega-3-acid ethyl esters | 120 in 1 BOTTLE | CAPSULE | 120 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-761 | OMEGA-3-ACID ETHYL ESTERS CAPSULE [STRIDES PHARMA SCIENCE LIMITED] | 6 | Legacy NDC, 3 package rows | 20211005_9499c40e-6665-4fbf-914d-1a9931b93562.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 |
|---|
| 64380-761-01 | 64380076101 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 64380-761-02 | 64380076102 | 5 BLISTER PACK in 1 CARTON (64380-761-02) > 10 CAPSULE in 1 BLISTER PACK (64380-761-01) | 5 blister pack | 2021-11-30 | 0000-00-00 | No | No | Current |
| 64380-761-11 | 64380076111 | 120 CAPSULE in 1 BOTTLE (64380-761-11) | 120 capsule | 2019-01-18 | 0000-00-00 | No | No | Current |