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 |
|---|---|---|---|---|---|---|
| BM Sodium bicarbonate (Nat Bicarb) | SODIUM BICARBONATE | BM Private Limited | 38044eae-7237-6add-e063-6294a90a827b | 2025-12-02 | Warnings | 8MDF5V39QO |
| Omeprazole and Sodium Bicarbonate | OMEPRAZOLE AND SODIUM BICARBONATE | Ajanta Pharma USA Inc. | bd84ca00-6352-4cb3-bce2-05f4a5005a94 | 2025-11-30 | Warnings, Adverse reactions | 8MDF5V39QO |
| Sodium Bicarbonate | SODIUM BICARBONATE | Civica | a10fdfbc-94a0-49ab-b26c-de1df042bc89 | 2025-11-24 | Warnings, Adverse reactions | 8MDF5V39QO |
| SODIUM BICARBONATE | SODIUM BICARBONATE | Glenmark Pharmaceuticals Inc., USA | f38d0dfc-9bcc-4224-a202-885c9ad0beae | 2025-11-20 | Warnings, Adverse reactions | 8MDF5V39QO |
| Itch Eraser Sensitive | SODIUM BICARBONATE | Tender Corporation d/b/a Adventure Ready Brands | 2250525a-45c2-42ea-e063-6394a90ac001 | 2025-11-18 | Warnings | 8MDF5V39QO |
| After Bite Kids | SODIUM BICARBONATE | Tender Corporation d/b/a Adventure Ready Brands | 226c1420-d771-204f-e063-6294a90af9f6 | 2025-11-18 | Warnings | 8MDF5V39QO |
| Alka-Seltzer Original | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | R J General Corporation | dbb0d067-71f0-45e4-bc98-548cf4a90b3a | 2025-11-17 | Warnings | 8MDF5V39QO |
| After Bite X Tech | SODIUM BICARBONATE | Adventure Ready Brands | e9e49ab4-3e1f-9fd4-e053-2a95a90a775a | 2025-11-17 | Warnings | 8MDF5V39QO |
| QUABIC-100 | HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION | Aqua Medica, S.A. de C.V. | 1484a825-40c6-a9c9-e063-6294a90a9ca4 | 2025-11-10 | Warnings | 8MDF5V39QO |
| GURUNANDA NASAL SALINE | NASAL WASH | GURUNANDA LLC | 27dbf0bf-c273-2108-e063-6394a90a0a09 | 2025-11-10 | Warnings | 8MDF5V39QO |
| QUABIC-100 | HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION | Aqua Medica, S.A. de C.V. | 28152c9f-b15c-3707-e063-6394a90a70e9 | 2025-11-10 | Warnings | 8MDF5V39QO |
| QUABIC-300 | HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION | Aqua Medica, S.A. de C.V. | c3cd7f0f-8d70-23af-e053-2a95a90a569b | 2025-11-10 | Warnings | 8MDF5V39QO |
| SODIUM BICARBONATE | SODIUM BICARBONATE | Henry Schein, Inc. | da484a2f-154f-48b4-8467-7a86729204c3 | 2025-11-07 | Warnings, Adverse reactions | 8MDF5V39QO |
| Sodium Bicarbonate | SODIUM BICARBONATE | Hospira, Inc. | ea20a5eb-641e-48cd-bcfa-74c04c45dfda | 2025-11-06 | Warnings, Adverse reactions | 8MDF5V39QO |
| CEO-TWO | LAXATIVE | Beutlich Pharmaceuticals, LLC | 08670636-5795-4db0-e063-6294a90afa4b | 2025-11-05 | Warnings | 8MDF5V39QO |
| Omeprazole and sodium bicarbonate | OMEPRAZOLE, SODIUM BICARBONATE | Walgreen Company | 8753a131-f8b1-48e1-993b-73c1ee635fef | 2025-11-04 | Warnings | 8MDF5V39QO |
| Omeprazole and Sodium Bicarbonate | OMEPRAZOLE, SODIUM BICARBONATE | CVS Pharmacy | 186732a3-13b9-4ea2-ba54-424f63298a2e | 2025-11-04 | Warnings | 8MDF5V39QO |
| basic care omeprazole and sodium bicarbonate | OMEPRAZOLE, SODIUM BICARBONATE | Amazon.com Services LLC | 4587f491-04ef-4c31-b7b6-bfafd31776fb | 2025-11-04 | Warnings | 8MDF5V39QO |
| Omeprazole and sodium bicarbonate | OMEPRAZOLE, SODIUM BICARBONATE | H E B | ddc8d73f-f4a1-42a7-89ee-420346820f61 | 2025-11-03 | Warnings | 8MDF5V39QO |
| Walgreens Antacid Pain Relief Extra Strength | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Walgreens | b60df498-07db-500b-e053-2a95a90aff6a | 2025-10-17 | Warnings | 8MDF5V39QO |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.