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 monohydrate | AZITHROMYCIN MONOHYDRATE | Gland Pharma Limited | 55051e03-b6dc-4bc6-87c1-e4fb84b61fa3 | 2026-08-12 | Warnings, Adverse reactions | 1668238 JTE4MNN1MD |
| IDkit HP ONE | CITRIC ACID ANHYDROUS AND 13C UREA | Meridian Bioscience Israel Ltd | 8baab7a7-5d20-46ad-9c4a-762992ef6b51 | 2026-07-28 | Warnings, Adverse reactions | 2968PHW8QP |
| Azithromycin | AZITHROMYCIN | Eugia US LLC | 7b81436e-d14a-4353-a22d-253f45e2e576 | 2026-07-27 | Warnings, Adverse reactions | 1668238 JTE4MNN1MD |
| Zithromax | AZITHROMYCIN DIHYDRATE | Pfizer Laboratories Div Pfizer Inc | 3b631aa1-2d46-40bc-a614-d698301ea4f9 | 2026-07-24 | Warnings, Adverse reactions | 1668238 |
| Azithromycin | AZITHROMYCIN | REMEDYREPACK INC. | 333ffe63-aaeb-4dff-b595-1c11209189a6 | 2026-07-01 | Warnings, Adverse reactions | JTE4MNN1MD |
| AZITHROMYCIN | AZITHROMYCIN | A-S Medication Solutions | 76093152-e2d7-4fe1-8568-1f0fec1747c2 | 2026-07-01 | Warnings, Adverse reactions | JTE4MNN1MD |
| Azithromycin | AZITHROMYCIN | REMEDYREPACK INC. | 943b9246-7733-44b1-875c-91d2ade78ac4 | 2026-06-29 | Warnings, Adverse reactions | JTE4MNN1MD |
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fd8a72-0527-df0c-e063-6294a90abe75 | 2026-06-24 | 2968PHW8QP | |
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fddca1-b40c-7af0-e063-6294a90a410e | 2026-06-24 | 2968PHW8QP | |
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fdf83e-f641-1f69-e063-6394a90ab750 | 2026-06-24 | 2968PHW8QP | |
| ACD A | CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE | Terumo BCT, Ltd. | 395aec48-198a-4aed-8e38-7accfb3232f9 | 2026-06-15 | Warnings, Adverse reactions | 2968PHW8QP |
| GUNA-CELL | ACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINC | Guna spa | 90db80ed-c037-4e8f-a7f6-304a65f9fe22 | 2026-06-11 | Warnings | 2968PHW8QP |
| GUNA-FLAM | ACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - | Guna spa | 7bda7eb0-8fd5-42d9-b336-39920bfc964d | 2026-06-10 | Warnings | 2968PHW8QP |
| ACD A | CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE | Terumo BCT, Ltd | 8e255bc7-a120-460a-a32d-43931f8115de | 2026-05-21 | Warnings, Adverse reactions | 2968PHW8QP |
| Azithromycin | AZITHROMYCIN | Sportpharm LLC | 397471e5-76e2-462c-af30-bcc54fe00266 | 2026-04-24 | Warnings, Adverse reactions | JTE4MNN1MD |
| 83801327-8c75-418e-948b-7e984782ed1e | 62f6f327-3fef-49f0-ae90-078356d002b5 | 2026-04-15 | Warnings, Adverse reactions | 62f6f327-3fef-49f0-ae90-078356d002b5 | ||
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID | Chartwell Governmental & Specialty RX, LLC | 58c24504-47de-487a-ab8d-18add155ea95 | 2026-04-07 | Adverse reactions | 2968PHW8QP |
| AZITHROMYCIN | AZITHROMYCIN | Preferred Pharmaceuticals, Inc. | 9e4fbd52-43e4-4d87-a136-f4d680a8d0c1 | 2026-03-12 | Warnings, Adverse reactions | JTE4MNN1MD |
| Azithromycin | AZITHROMYCIN | Preferred Pharmaceuticals Inc. | ac327054-21ab-401c-a27a-48259db18f89 | 2026-03-11 | Warnings, Adverse reactions | JTE4MNN1MD |
| Tricitrates | TRICITRATES | Chartwell Governmental & Specialty RX, LLC. | c4ff0407-3930-4c48-afd4-d2cb3e1b18f4 | 2026-02-25 | Warnings, Adverse reactions | 2968PHW8QP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.