Ampicillin and Sulbactam
- Product NDC
- 0641-6117
- 11-digit product format
- 006416117
- Labeler code
- 0641
- Product ID
- 0641-6117_c0a3fa06-81d0-410a-8f9b-2be2b03fdc3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ampicillin and Sulbactam
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA065406
- Marketing category
- ANDA
- Marketing start
- 2009-12-22
- Substance
- AMPICILLIN SODIUM; SULBACTAM SODIUM
- Active strength
- 2; 1 g/3g; g/3g
- 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 | 2 g/3g |
| SULBACTAM SODIUM | 1 g/3g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DKQ4T82YE6, JFN36L5S8K |
| Rxcui | 1659592, 1659598 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6117-01 | Ampicillin and Sulbactam | 3 g in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 3 | | 10 |
| 0641-6117-10 | Ampicillin and Sulbactam | 10 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 10 | | 10 |
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.] | 4 | |
| SULBACTAM SODIUM | ACTIVE INGREDIENT | DKQ4T82YE6 | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.] | 4 | |
| AMPICILLIN | ACTIVE MOIETY | 7C782967RD | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.] | 4 | |
| SULBACTAM | ACTIVE MOIETY | S4TF6I2330 | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6117 | AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240926_d3026cc0-95d8-44cf-be47-b5ebb8fd4568.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 |
|---|
| 0641-6117-01 | 00641611701 | 3 g in 1 VIAL | 3 g | | | | | Historical |
| 0641-6117-10 | 00641611710 | 10 VIAL in 1 CARTON (0641-6117-10) / 3 g in 1 VIAL (0641-6117-01) | 10 vial | 2009-12-22 | 0000-00-00 | No | No | Current |