ALVIMOPAN
- Product NDC
- 0254-3012
- 11-digit product format
- 002543012
- Labeler code
- 0254
- Product ID
- 0254-3012_d43941f1-7b52-4e7a-a560-9a8e28a7ac65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ALVIMOPAN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA216843
- Marketing category
- ANDA
- Marketing start
- 2023-05-03
- Substance
- ALVIMOPAN
- Active strength
- 12 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ALVIMOPAN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALVIMOPAN | 12 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 677C126AET |
| Rxcui | 799835 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0254-3012-55 | ALVIMOPAN | 6 in 1 CARTON | CAPSULE | 6 | | 12 |
| 0254-3012-55 | ALVIMOPAN | 5 in 1 BLISTER PACK | CAPSULE | 5 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0254-3012 | ALVIMOPAN CAPSULE [ENDO USA, INC.] | 9 | Current NDC, 2 package rows | 20240725_1cd584de-b704-4d26-8451-e3247ffb8d08.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0254-3012-55 | 00254301255 | 6 BLISTER PACK in 1 CARTON (0254-3012-55) / 5 CAPSULE in 1 BLISTER PACK | 6 blister pack | 2023-05-03 | No | No | Historical |