Alvimopan
- Product NDC
- 0054-0668
- 11-digit product format
- 000540668
- Labeler code
- 0054
- Product ID
- 0054-0668_89b02f3c-d8da-4b1f-9847-859c4efffabb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alvimopan
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA217753
- Marketing category
- ANDA
- Marketing start
- 2024-02-06
- 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 |
|---|
| 0054-0668-82 | Alvimopan | 6 in 1 CARTON | CAPSULE | 6 | | 2 |
| 0054-0668-82 | Alvimopan | 5 in 1 BLISTER PACK | CAPSULE | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0668 | ALVIMOPAN CAPSULE [HIKMA PHARMACEUTICALS USA INC.] | 2 | Current NDC, 2 package rows | 20240207_59ef406b-79db-4efd-b993-08b937ac682b.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 |
|---|
| 0054-0668-82 | 00054066882 | 6 BLISTER PACK in 1 CARTON (0054-0668-82) / 5 CAPSULE in 1 BLISTER PACK | 6 blister pack | 2024-02-06 | No | No | Historical |