Ampicillin and Sulbactam
- Product NDC
- 70594-082
- 11-digit product format
- 705940082
- Labeler code
- 70594
- Product ID
- 70594-082_4ca436da-1f5a-49da-ae27-50409f8357de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMPICILLIN SODIUM and SULBACTAM SODIUM
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Xellia Pharmaceuticals USA LLC
- Application
- ANDA090579
- Marketing category
- ANDA
- Marketing start
- 2021-01-10
- Marketing end
- 0000-00-00
- Substance
- AMPICILLIN SODIUM; SULBACTAM SODIUM
- Active strength
- 2 g/1; g/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70594-082 | AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] | 4 | Legacy NDC | 20241212_7161f386-6373-4db5-8dfd-d7ddf38ec2f1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70594-082-02 | 70594008202 | 10 VIAL in 1 CARTON (70594-082-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-082-01) | 10 vial | 2021-01-10 | 0000-00-00 | No | No | Current |