FLEXBUMIN
- Product NDC
- 0944-0493
- Requested package NDC
- 0944-0493-02
- 11-digit product format
- 009440493
- Labeler code
- 0944
- Product ID
- 0944-0493_176823b1-a331-44a1-8344-87a8ff7a8f9a
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Albumin Human
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- BLA101452
- Marketing category
- BLA
- Marketing start
- 2002-08-09
- Substance
- ALBUMIN HUMAN
- Active strength
- .25 g/mL
- Pharmacologic classes
- Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLEXBUMIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALBUMIN HUMAN | .25 g/mL |
Harmonized UNII identifiers#
UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| ZIF514RVZR | Internal UNII lookup |
Harmonized RxCUI identifiers#
RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 1741375 | Internal RxNorm lookup |
| 1741380 | Internal RxNorm lookup |
| 1742401 | Internal RxNorm lookup |
| 1742403 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0944-0493-01 | FLEXBUMIN | 12 in 1 CARTON | SOLUTION | 12 | | 17 |
| 0944-0493-02 | FLEXBUMIN | 6 in 1 CARTON | SOLUTION | 6 | | 17 |
| 0944-0493-03 | FLEXBUMIN | 50 mL in 1 BAG | SOLUTION | 50 | | 17 |
| 0944-0493-04 | FLEXBUMIN | 100 mL in 1 BAG | SOLUTION | 100 | | 17 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0944-0493 | FLEXBUMIN (ALBUMIN HUMAN) SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 17 | Current NDC, Legacy NDC, 4 package rows | 20241222_bdb4e167-27a2-4b50-b245-43df9cd535cb.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 101452 | Buminate, Flexbumin | Albumin (Human) | 351(a) | Rx | 2026-10-01 |
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 |
|---|
| 0944-0493-02 | 00944049302 | 6 BAG in 1 CARTON (0944-0493-02) / 100 mL in 1 BAG (0944-0493-04) | 6 bag | 2002-08-09 | 0000-00-00 | No | No | Current |