Zosyn
- Product NDC
- 0338-9638
- 11-digit product format
- 003389638
- Labeler code
- 0338
- Product ID
- 0338-9638_d1d6e9c8-a033-4e26-a687-e6325808fa0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- piperacillin sodium and tazobactam sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- NDA050750
- Marketing category
- NDA
- Marketing start
- 2023-04-01
- Substance
- PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
- Active strength
- 4; .5 g/100mL; g/100mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zosyn
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PIPERACILLIN SODIUM | 4 g/100mL |
| TAZOBACTAM SODIUM | .5 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UXA545ABTT, M98T69Q7HP |
| Rxcui | 1659131, 1659134, 1659137, 1659139, 1659149, 1659151 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0338-9638-01 | Zosyn | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 6 |
| 0338-9638-12 | Zosyn | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0338-9638 | ZOSYN (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 5 | Current NDC, 2 package rows | 20241211_8db6bd91-2106-4bfd-8cc8-38aaf1e18d17.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0338-9638-01 | 00338963801 | 100 mL in 1 BAG | 100 ml | | | | Historical |
| 0338-9638-12 | 00338963812 | 12 BAG in 1 CARTON (0338-9638-12) / 100 mL in 1 BAG (0338-9638-01) | 12 bag | 2023-04-01 | No | No | Historical |