Pomalidomide
- Product NDC
- 51991-346
- 11-digit product format
- 519910346
- Labeler code
- 51991
- Product ID
- 51991-346_44621941-eb2e-421f-bcf0-ed39d4de70f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pomalidomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA210111
- Marketing category
- ANDA
- Marketing start
- 2026-02-28
- Substance
- POMALIDOMIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Thalidomide Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pomalidomide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POMALIDOMIDE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D2UX06XLB5 |
| Rxcui | 1369718, 1369726, 1369730, 1369734 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51991-346-01 | Pomalidomide | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 51991-346-21 | Pomalidomide | 21 in 1 BOTTLE, PLASTIC | CAPSULE | 21 | | 10 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51991-346-01 | 51991034601 | 100 in 1 BOTTLE | | | | | Historical |
| 51991-346-21 | 51991034621 | 21 CAPSULE in 1 BOTTLE, PLASTIC (51991-346-21) | 21 capsule | 2026-02-28 | No | No | Historical |