Protamine Sulfate
- Product NDC
- 65219-646
- 11-digit product format
- 652190646
- Labeler code
- 65219
- Product ID
- 65219-646_c76876da-b9a8-45d0-9278-7df3288d3a06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROTAMINE SULFATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA089454
- Marketing category
- ANDA
- Marketing start
- 2025-03-28
- Substance
- PROTAMINE SULFATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Protamine Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROTAMINE SULFATE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0DE9724IHC |
| Rxcui | 1796672 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-646-02 | Protamine Sulfate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 1 |
| 65219-646-05 | Protamine Sulfate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-646 | PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 2 package rows | 20250515_c76876da-b9a8-45d0-9278-7df3288d3a06.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 |
|---|
| 65219-646-02 | 65219064602 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | Historical |
| 65219-646-05 | 65219064605 | 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02) | | 2025-03-28 | No | No | Historical |