UNASYN
- Product NDC
- 0049-0024
- 11-digit product format
- 000490024
- Labeler code
- 0049
- Product ID
- 0049-0024_f96b8c10-d100-47bd-9c4a-3bcce67b1758
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ampicillin sodium and sulbactam sodium
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Roerig
- Application
- NDA050608
- Marketing category
- NDA
- Marketing start
- 1991-11-22
- 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
- UNASYN
- 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 | 205843, 240984 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0049-0024-28 | UNASYN | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, POWDER, FOR SOLUTION | 100 | | 39 |
| 0049-0024-28 | UNASYN | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 39 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMPICILLIN SODIUM | ACTIVE INGREDIENT | JFN36L5S8K | UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG] | 16 | |
| SULBACTAM SODIUM | ACTIVE INGREDIENT | DKQ4T82YE6 | UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG] | 16 | |
| AMPICILLIN | ACTIVE MOIETY | 7C782967RD | UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG] | 16 | |
| SULBACTAM | ACTIVE MOIETY | S4TF6I2330 | UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG] | 16 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0049-0024 | UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG] | 39 | Current NDC, Legacy NDC, 2 package rows | 20250515_12eeb72a-403d-41be-bae4-4cb930862884.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0049-0024-28 | 00049002428 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0049-0024-28) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 1991-11-22 | 0000-00-00 | No | No | Current |