NDC 0641-6119-01 - Ampicillin and Sulbactam
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0641-6119
- Requested NDC
- 0641-6119-01
- Package NDCs from labels
- 0641-6119-01, 0641-6119-10
- Manufacturer
- Hikma Pharmaceuticals USA Inc. | MITIM SRL
- Effective date
- 2019-12-30
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Ampicillin and Sulbactam - Hikma Pharmaceuticals USA Inc. | MITIM SRL | Hikma Pharmaceuticals USA Inc. | MITIM SRL | 2019-12-30 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0641-6119-10 | 2025-03-12 | C162847 | 48780-1 | 2cef2736-82c7-d83d-e063-dadaa90ab31f | AMPICILLIN AND SULBACTAM FOR INJECTION, USP |
| 0641-6119-10 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-82c7-d83d-e063-dadaa90ab31f | AMPICILLIN AND SULBACTAM FOR INJECTION, USP |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6119-01 | EA - Each | 0641-6119 | 895d1de9-7a6b-4e1f-a91a-b231de77c99c | 1 | 2012-07-24 |
| 0641-6119-10 | EA - Each | 0641-6119 | da754f59-e84b-4e95-b355-e4a260d49d96 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| 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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ampicillin | AMPICILLIN | Medical Purchasing Solutions, LLC | bbf118c0-7cd3-5a82-e053-2a95a90ac8c8 | 2023-05-08 | Warnings, Adverse reactions | JFN36L5S8K |
| Ampicillin | AMPICILLIN | Medical Purchasing Solutions, LLC | c4310ee5-cbd3-99b5-e053-2995a90ae229 | 2023-04-27 | Warnings, Adverse reactions | JFN36L5S8K |
| Ampicillin | AMPICILLIN SODIUM | Fresenius Kabi USA, LLC | 8dbb4c71-8543-08f1-e053-2995a90af88d | 2022-10-21 | Warnings, Adverse reactions | JFN36L5S8K |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.