Ampicillin and Sulbactam
- Product NDC
- 0641-6118
- 11-digit product format
- 006416118
- Labeler code
- 0641
- Product ID
- 0641-6118_43dd9102-1a8e-47c9-a65c-fc50ab4bbf5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ampicillin and Sulbactam
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA065403
- Marketing category
- ANDA
- Marketing start
- 2009-12-03
- Substance
- AMPICILLIN SODIUM; SULBACTAM SODIUM
- Active strength
- 100; 50 mg/mL; mg/mL
- 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMPICILLIN SODIUM | 100 mg/mL |
| SULBACTAM SODIUM | 50 mg/mL |
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 |
|---|
| 0641-6118-01 | Ampicillin and Sulbactam | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, POWDER, FOR SOLUTION | 100 | | 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 [WEST-WARD PHARMACEUTICAL CORP.] | 5 | |
| SULBACTAM SODIUM | ACTIVE INGREDIENT | DKQ4T82YE6 | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.] | 5 | |
| AMPICILLIN | ACTIVE MOIETY | 7C782967RD | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.] | 5 | |
| SULBACTAM | ACTIVE MOIETY | S4TF6I2330 | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6118 | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20240809_a65a70bf-4283-4bc0-b576-00c9ab29bd64.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 |
|---|
| 0641-6118-01 | 00641611801 | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) | 100 ml | 2009-12-03 | 0000-00-00 | No | No | Current |