NDC 63323-398-01 - Azithromycin
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
- 63323-398
- Requested NDC
- 63323-398-01
- Package NDCs from labels
- 63323-398-01, 63323-398-10, 63323-398-41, 63323-398-14, 63323-398-12
- Manufacturer
- Fresenius Kabi USA, LLC
- Effective date
- 2024-10-11
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Azithromycin - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2024-10-11 | HUMAN PRESCRIPTION DRUG LABEL |
| Azithromycin - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2024-10-11 | HUMAN PRESCRIPTION DRUG LABEL |
| Azithromycin - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2024-10-11 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-398-01 | Azithromycin | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | 8 | |
| 63323-398-10 | Azithromycin | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | 8 | |
| 63323-398-14 | Azithromycin | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | 4 | |
| 63323-398-41 | Azithromycin | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-398 | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241018_b69917c0-95d5-4b29-b0e3-07054a4fd79f.zip |
| 63323-398 | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241018_9ad099d5-5c57-4855-98a4-e03fb4629dbf.zip |
| 63323-398 | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | Current NDC, Legacy NDC | 20241018_62f6f327-3fef-49f0-ae90-078356d002b5.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-398-01 | EA - Each | 63323-398 | ee95010a-cd05-45d8-a81a-e229af268f31 | 1 | 2024-04-05 |
| 63323-398-10 | EA - Each | 63323-398 | 70ccab4e-3d2b-47c5-8bea-1693038f96ae | 1 | 2012-07-24 |
| 63323-398-12 | EA - Each | 63323-398 | c7f52582-24e3-4fdb-910e-7e1cef7c48da | 1 | 2014-02-04 |
| 63323-398-14 | EA - Each | 63323-398 | a7f887ec-a04b-4a90-bc10-ef967647beb5 | 1 | 2014-08-01 |
| 63323-398-41 | EA - Each | 63323-398 | 09dabf8c-0f7b-4cf3-8b9c-d99debb0d5dd | 1 | 2024-04-05 |
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 |
|---|---|---|---|---|---|---|
| AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | e1172805-0930-4fb9-8a2f-e0d6a0430630 | 2022-11-01 | Warnings, Adverse reactions | JTE4MNN1MD |
| AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | b3761d39-9b79-4908-8b05-a1c91e599998 | 2022-11-01 | Warnings, Adverse reactions | JTE4MNN1MD |
| Azithromycin | AZITHROMYCIN MONOHYDRATE | PharmPak, Inc. | ba57ff26-cd02-4f57-ac92-b613d245a4ea | 2022-10-14 | Warnings, Adverse reactions | JTE4MNN1MD |
| Azithromycin | AZITHROMYCIN | Proficient Rx LP | 7e7c2f49-449c-4ba2-98ae-0ff0c040614c | 2022-10-01 | Warnings, Adverse reactions | JTE4MNN1MD |
| GUNA FLAM RELIEF | ACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND - | Guna spa | af5a9c74-e1c7-6574-e053-2995a90a3d10 | 2020-09-15 | Warnings | 2968PHW8QP |
| Azithromycin | AZITHROMYCIN | Sun Pharmaceutical Industries, Inc. | 6a22beb6-57e8-480d-97b5-44d9dbfabf93 | 2020-04-06 | Warnings, Adverse reactions | 1668238 JTE4MNN1MD |
| GUNA-ALLERGY-PREV | AMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT - | Guna spa | adae93c0-1de9-4e45-ab58-148171f0dc86 | 2018-12-21 | Warnings | 2968PHW8QP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.