Ampicillin and Sulbactam
- Product NDC
- 44567-212
- 11-digit product format
- 445670212
- Labeler code
- 44567
- Product ID
- 44567-212_6db840e0-7805-4daa-b8b9-aa6f1f46fd10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ampicillin and Sulbactam
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- WG Critical Care, LLC
- Application
- ANDA065188
- Marketing category
- ANDA
- Marketing start
- 2005-11-25
- Substance
- AMPICILLIN SODIUM; SULBACTAM SODIUM
- Active strength
- 10; 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
- Ampicillin and Sulbactam
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMPICILLIN SODIUM | 10 g/100mL |
| SULBACTAM SODIUM | 5 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JFN36L5S8K, DKQ4T82YE6 |
| Rxcui | 240984 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 44567-212-01 | Ampicillin and Sulbactam | 100 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 100 | | 11 |
| 44567-212-01 | Ampicillin and Sulbactam | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMPICILLIN SODIUM | ACTIVE INGREDIENT | JFN36L5S8K | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] | 4 | |
| SULBACTAM SODIUM | ACTIVE INGREDIENT | DKQ4T82YE6 | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] | 4 | |
| AMPICILLIN | ACTIVE MOIETY | 7C782967RD | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] | 4 | |
| SULBACTAM | ACTIVE MOIETY | S4TF6I2330 | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44567-212 | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240809_77158167-0c1e-4f01-a5b0-a3df8ad121f5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 44567-212-01 | 44567021201 | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL | 1 vial | 2015-11-25 | 0000-00-00 | No | No | Current |