PROTAMINE SULFATE
- Product NDC
- 51662-1414
- 11-digit product format
- 516621414
- Labeler code
- 51662
- Product ID
- 51662-1414_0f90d77c-0de8-d2a3-e063-6394a90a067d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROTAMINE SULFATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA089454
- Marketing category
- ANDA
- Marketing start
- 2019-10-13
- 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 |
|---|
| 51662-1414-1 | PROTAMINE SULFATE | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 4 |
| 51662-1414-2 | PROTAMINE SULFATE | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 4 |
| 51662-1414-2 | PROTAMINE SULFATE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 4 |
| 51662-1414-3 | PROTAMINE SULFATE | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1414 | PROTAMINE SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240123_94d4f57f-940e-c0a8-e053-2a95a90ae3af.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 |
|---|
| 51662-1414-1 | 51662141401 | 5 mL in 1 VIAL, SINGLE-DOSE (51662-1414-1) | 5 ml | 2019-10-13 | 0000-00-00 | No | No | Current |
| 51662-1414-2 | 51662141402 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | | Historical |
| 51662-1414-3 | 51662141403 | 25 POUCH in 1 CASE (51662-1414-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1414-2) / 5 mL in 1 VIAL, SINGLE-DOSE | 25 pouch | 2023-06-16 | | No | No | Historical |