Alvimopan
- Product NDC
- 0591-2312
- 11-digit product format
- 005912312
- Labeler code
- 0591
- Product ID
- 0591-2312_ef9ffdef-f019-4329-b6a4-658fa872d3b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alvimopan
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA208295
- Marketing category
- ANDA
- Marketing start
- 2020-12-01
- Substance
- ALVIMOPAN
- Active strength
- 12 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alvimopan
- Listing expiration
- 2026-12-31
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 |
|---|
| 0591-2312-15 | Alvimopan | 30 in 1 CARTON | CAPSULE | 30 | | 5 |
| 0591-2312-45 | Alvimopan | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2312 | ALVIMOPAN CAPSULE [ACTAVIS PHARMA, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240125_2a0645b4-daf8-421f-b987-a4e478843c5d.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 |
|---|
| 0591-2312-00 | 00591231200 | 20000 CAPSULE in 1 BOX (0591-2312-00) | 20000 capsule | 13-OCT-20 | | | | Current |
| 0591-2312-15 | 00591231215 | 30 BLISTER PACK in 1 CARTON (0591-2312-15) / 1 CAPSULE in 1 BLISTER PACK (0591-2312-45) | 30 blister pack | 2020-12-01 | 0000-00-00 | No | No | Current |
| 0591-2312-45 | 00591231245 | 1 in 1 BLISTER PACK | | | | | | Historical |