Details for New Drug Application (NDA): 019953
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NDA 019953 describes HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, which is a drug marketed by B Braun and Hospira and is included in three NDAs. It is available from three suppliers. Additional details are available on the HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER profile page.
The generic ingredient in HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
The generic ingredient in HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 019953
| Tradename: | HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
| Applicant: | B Braun |
| Ingredient: | heparin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 019953
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | heparin sodium | INJECTABLE;INJECTION | 019953 | NDA | B. Braun Medical Inc. | 0264-3301 | 0264-3301-10 | 24 CONTAINER in 1 CASE (0264-3301-10) / 500 mL in 1 CONTAINER |
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | heparin sodium | INJECTABLE;INJECTION | 019953 | NDA | B. Braun Medical Inc. | 0264-3462 | 0264-3462-20 | 24 CONTAINER in 1 CASE (0264-3462-20) / 250 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200 UNITS/100ML | ||||
| Approval Date: | Jul 20, 1992 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200 UNITS/100ML | ||||
| Approval Date: | Dec 15, 2023 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5,000 UNITS/100ML | ||||
| Approval Date: | Mar 25, 2025 | TE: | RLD: | Yes | |||||
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