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 |
|---|---|---|---|---|---|---|
| Potassium Citrate and Citric Acid | POTASSIUM CITRATE AND CITRIC ACID | Chartwell Governmental & Specialty RX, LLC. | fd57a176-7faf-4053-b348-6ba5f192f05a | 2026-02-25 | Warnings, Adverse reactions | 2968PHW8QP |
| AZITHROMYCIN | AZITHROMYCIN | A-S Medication Solutions | 405ab07f-7d1d-4552-ad3b-2a03be8e9949 | 2026-02-17 | Warnings, Adverse reactions | JTE4MNN1MD |
| AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | 59c4b783-4ff7-4269-969b-58a10e12b12b | 2026-02-04 | Warnings, Adverse reactions | JTE4MNN1MD |
| Azithromycin | AZITHROMYCIN | Sportpharm LLC | 5f9e13f5-69ee-4220-90d9-31fa8660d880 | 2026-02-03 | Warnings, Adverse reactions | JTE4MNN1MD |
| Additive Formula 3 | DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINE | Terumo BCT, Ltd | 9a5247a1-cc05-442d-b2d0-950f887f03c2 | 2026-01-30 | Warnings, Adverse reactions | 2968PHW8QP |
| SWISS BLEU Relief-Calm Antimicrobial Skin Cream | LACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACID | Nanjing Hongruixing Biological Technology Co., Ltd | 487d3c2c-ce28-f7a1-e063-6294a90a5ec6 | 2026-01-16 | Warnings | 2968PHW8QP |
| Azithromycin | AZITHROMYCIN | AvKARE | 16da30a2-d11c-7e8c-e063-6294a90a62e3 | 2026-01-13 | Warnings, Adverse reactions | JTE4MNN1MD |
| Sterile Cord Blood Collection Unit (MSC128D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION | Maco Productions | 251fd4cb-4aa4-4473-9f89-968da856eb77 | 2025-12-18 | Warnings | 2968PHW8QP |
| Sterile Cord Blood Collection Unit (MSC127D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION | Maco Productions | 75a008b2-9666-4bfa-ab18-6d09b43b2215 | 2025-12-18 | Warnings | 2968PHW8QP |
| Pall Sterile Cord Blood Collection Unit | STERILE CORD BLOOD COLLECTION UNIT | Global Life Sciences Solutions USA LLC | aa9340b7-cc63-e17d-e053-2a95a90ad4d9 | 2025-12-18 | Warnings | 2968PHW8QP |
| STERILE CORD BLOOD COLLECTION UNIT (MSC123D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE | Maco Productions | e3b456ec-4578-485f-a696-8a343505f30b | 2025-12-16 | Warnings | 2968PHW8QP |
| PaxLyte | LEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULE | Jaymac Pharmaceuticals | f520b130-61b3-443e-aaf6-91e094e7a334 | 2025-12-08 | Warnings, Adverse reactions | 2968PHW8QP |
| Alka-Seltzer Heartburn | ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED) | Bayer HealthCare LLC. | 55158e50-0327-2043-e054-00144ff8d46c | 2025-12-04 | Warnings | 2968PHW8QP |
| Alka-Seltzer Gold | ALKA-SELTZER GOLD | Bayer HealthCare LLC. | 0824bedb-413b-2fa0-e054-00144ff88e88 | 2025-12-04 | Warnings | 2968PHW8QP |
| AZITHROMYCIN | AZITHROMYCIN | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 714f6f55-278a-4fcf-8d4e-2ad9b43623a3 | 2025-11-20 | Warnings, Adverse reactions | JTE4MNN1MD |
| Earthmed Soothe Chewable Orange | CITRIC ACID | Earthmed LLC | 439543fe-ceb9-4c5c-e063-6294a90a9b70 | 2025-11-14 | Warnings | 2968PHW8QP |
| AQUACETIC-30 | CLEANING SOLUTION FOR HEMODIALYSIS MACHINES | Aqua Medica, S.A. de C.V. | 040775ab-41bd-cd36-e063-6394a90a08aa | 2025-11-10 | Warnings | 2968PHW8QP |
| CITRACID-50 | DESINFECTANT SOLUTION FOR HEMODIALYSIS MACHINE | Aqua Medica, S.A. de C.V. | 040713e7-67cd-8eb0-e063-6394a90aa2a9 | 2025-11-10 | Warnings | 2968PHW8QP |
| AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals, Inc. | 3f7c7421-411d-c04e-e063-6394a90a4aa0 | 2025-09-23 | Warnings, Adverse reactions | JTE4MNN1MD |
| Medique Medi Seltzer | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Unifirst First Aid Corporation | 528da9d9-2a52-4c16-b7b2-61b3eee1abea | 2025-08-19 | Warnings | 2968PHW8QP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.