NDC 63323-322-01 - Imipenem and Cilastatin
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
- 63323-322
- Requested NDC
- 63323-322-01
- Package NDCs from labels
- 63323-322-21, 63323-322-93, 63323-322-41, 63323-322-94, 63323-322-01, 63323-322-25
- Manufacturer
- Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd
- Effective date
- 2022-10-11
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| IMIPENEM - Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd | Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd | 2022-10-11 | HUMAN PRESCRIPTION DRUG LABEL |
| IMIPENEM - Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd | Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd | 2022-10-10 | HUMAN PRESCRIPTION DRUG LABEL |
| IMIPENEM - Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd | Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd | 2022-10-06 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-322-01 | Imipenem and Cilastatin | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, FOR SOLUTION | 20 | 12 | |
| 63323-322-25 | Imipenem and Cilastatin | 25 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 25 | 12 | |
| 63323-322-41 | Imipenem and Cilastatin | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, FOR SOLUTION | 20 | 7 | |
| 63323-322-94 | Imipenem and Cilastatin | 25 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 25 | 7 | |
| 63323-322-21 | Imipenem and Cilastatin | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, FOR SOLUTION | 20 | 5 | |
| 63323-322-93 | Imipenem and Cilastatin | 25 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 25 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-322 | IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 12 | Current NDC, Legacy NDC, 2 package rows | 20221020_6ab0ca9e-9a79-4cab-9f09-470eda06952e.zip |
| 63323-322 | IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20221027_0a1dd9b9-ada1-4bff-9dcb-18961254e9e8.zip |
| 63323-322 | IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20221103_ce771566-c4f2-447e-944a-6b908925c90b.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-322-01 | EA - Each | 63323-322 | 34deeaf8-735f-4d5d-8ce0-f7bca735d05f | 1 | 2022-01-06 |
| 63323-322-20 | EA - Each | 63323-322 | 15d13752-d665-47b7-a49c-deac99c4cf15 | 1 | 2012-07-24 |
| 63323-322-21 | EA - Each | 63323-322 | f295eda5-5f73-456c-93a6-9c36771eb017 | 1 | 2022-04-06 |
| 63323-322-25 | EA - Each | 63323-322 | 3224fb37-f888-4ac9-943f-4fd3d043976d | 1 | 2013-02-13 |
| 63323-322-41 | EA - Each | 63323-322 | 1036c74b-ed3a-40f7-bbf1-87d3249cda17 | 1 | 2022-10-06 |
| 63323-322-93 | EA - Each | 63323-322 | 09ffc170-6c97-4df2-939c-49e83a8a41f7 | 1 | 2016-07-19 |
| 63323-322-94 | EA - Each | 63323-322 | 89f6cade-0bdd-4c18-b4ce-d0e9ff9c7655 | 1 | 2015-01-05 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Equate Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Walmart | 6271b34b-55a0-40a8-e053-2a91aa0acb22 | 2025-10-17 | Warnings, Adverse reactions | 8MDF5V39QO |
| EQUATE SALINE PACKETS | NASAL CLEANING SALT | WALMART INC | 9e905ecb-d4d5-514a-e053-2a95a90adfbb | 2025-10-08 | Warnings | 8MDF5V39QO |
| EQUATE NETI POT SINUS WASH | NASAL WASH | WALMART INC | 9e90c1c1-4dcd-106e-e053-2995a90afd15 | 2025-10-08 | Warnings | 8MDF5V39QO |
| GURUNANDA NASAL SALINE | NASAL WASH | GURUNANDA LLC | 2b4d78ae-b587-6dfe-e063-6394a90a8876 | 2025-10-08 | Warnings | 8MDF5V39QO |
| Omeprazole and Sodium Bicarbonate | OMEPRAZOLE AND SODIUM BICARBONATE | Ajanta Pharma USA Inc. | cb657607-b038-47ee-b4e7-a5f419a14c33 | 2025-10-06 | Warnings, Adverse reactions | 8MDF5V39QO |
| Sodium Bicarbonate | SODIUM BICARBONATE | Fresenius Kabi USA, LLC | 0ab55004-bb63-436d-ad77-cd3796905370 | 2025-09-23 | Warnings, Adverse reactions | 8MDF5V39QO |
| Stomachin Antacid | MAGNESIUM CARBONATE AND SODIUM BICARBONATE | Chang Kuo Chou Pharmaceutical Co., Ltd. | 60fa0650-8785-4cb3-8f88-1a437296252f | 2025-09-19 | Warnings | 8MDF5V39QO |
| GAVILYTE-N | POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE | Lupin Pharmaceuticals,Inc. | 27195187-75a3-431f-90d9-84da1b94e849 | 2025-09-10 | Warnings, Adverse reactions | 8MDF5V39QO |
| GaviLyte - C TM | POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK | Lupin Pharmaceuticals,Inc. | a8b15625-ca7c-4d57-9f36-3ac2a6d13665 | 2025-09-10 | Warnings, Adverse reactions | 8MDF5V39QO |
| GAVILYTE G TM | POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES | Lupin Pharmaceuticals,Inc. | 3978822b-6473-4072-9f80-20ceb9bea355 | 2025-09-10 | Warnings, Adverse reactions | 8MDF5V39QO |
| omeprazole and sodium bicarbonate | OMEPRAZOLE, SODIUM BICARBONATE | Meijer Distribution Inc | bb7c1c5d-b915-42f5-a5a2-5f61b088028d | 2025-09-05 | Warnings | 8MDF5V39QO |
| Polyethylene Glycol 3350 and electrolytes - Unflavored | POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED | Strides Pharma Science Limited | 48c741a9-9039-4fdb-a875-86d4ea968282 | 2025-09-05 | Warnings, Adverse reactions | 8MDF5V39QO |
| Sodium Bicarbonate 10 GR (650 MG) | SODIUM BICARBONATE | Advanced Rx LLC | 634e8d52-6d04-42f9-98f6-2634473b5dfd | 2025-09-01 | Warnings | 8MDF5V39QO |
| Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored | POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVORED | Strides Pharma Science Limited | 37c111ec-5b62-42b9-bbb2-3b0c530e34c9 | 2025-09-01 | Warnings, Adverse reactions | 8MDF5V39QO |
| Sodium Bicarbonate | SODIUM BICARBONATE | ProPharma Distribution | 3d71b046-3e0b-054a-e063-6294a90a563a | 2025-08-28 | Warnings, Adverse reactions | 8MDF5V39QO |
| Medique Medi Seltzer | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Unifirst First Aid Corporation | 528da9d9-2a52-4c16-b7b2-61b3eee1abea | 2025-08-19 | Warnings | 8MDF5V39QO |
| Sodium Bicarbonate | SODIUM BICARBONATE | Bryant Ranch Prepack | ccf8e08c-2efb-4a92-a4c2-042dba2eacfa | 2025-08-13 | Warnings, Adverse reactions | 8MDF5V39QO |
| Sodium Bicarbonate | SODIUM BICARBONATE | Henry Schein, Inc. | ea9ad1a6-84f2-44d8-bf93-fb8f3d3fce9c | 2025-08-12 | Warnings, Adverse reactions | 8MDF5V39QO |
| Bath Bomb 2-pack (Lemon) | ALLANTOIN | Carolina Cannabis Creations LLC | 08c7c313-cf36-fb46-e063-6294a90a7304 | 2025-08-06 | Warnings | 8MDF5V39QO |
| Omeprazole and Sodium Bicarbonate | OMEPRAZOLE AND SODIUM BICARBONATE | PHOENIX RX LLC | 3b2bf501-fd81-6ffa-e063-6394a90afe42 | 2025-07-30 | Warnings, Adverse reactions | 8MDF5V39QO |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.