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 table
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 table
Package NDC	Product	Description	Form	Quantity	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 table
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 table
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#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZITHROMYCIN MONOHYDRATE	ACTIVE INGREDIENT	JTE4MNN1MD	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	6
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	6
AZITHROMYCIN MONOHYDRATE	ACTIVE INGREDIENT	JTE4MNN1MD	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
AZITHROMYCIN MONOHYDRATE	ACTIVE INGREDIENT	JTE4MNN1MD	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1

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.

Matched openFDA labels page 4 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRICITRATES	POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE	PAI Holdings, LLC dba PAI Pharma	2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad	2024-11-15	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
Sal de Uvas Picot	CITRIC ACID MONOHYDRATE AND SODIUM BICARBONATE	RB Health Mexico, S.A. de C.V.	151b9bc9-1a6e-4401-ae58-4b4210ab4505	2024-11-15	Warnings	Exact identifier unii: 2968PHW8QP
Lungex II	GINKGO BILOBA, COLON (SUIS), LUNG (SUIS), PANCREAS SUIS, GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, MANGANUM METALLICUM, STANNUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, ARSENICUM METALLICUM, CALCAREA CARBONICA, ACONITICUM ACIDUM, CIS, NATRUM OXALACETICUM, PHOSPHORUS	Energique, Inc.	ddf7fc46-95b7-44b4-b7ca-96a066a3fa2b	2024-10-28	Warnings	Exact identifier unii: 2968PHW8QP
Azithromycin	AZITHROMYCIN MONOHYDRATE	Fresenius Kabi USA, LLC	b69917c0-95d5-4b29-b0e3-07054a4fd79f	2024-10-11	Warnings, Adverse reactions	Exact identifier application number: ANDA065179 ndc (package): 63323-398-01 ndc (package): 63323-398-10 ndc (product): 63323-398 ndc11 (package): 63323039801 rxcui: 1668238 spl id: 2143a7d1-6575-4d24-8ef4-001ecf2671e2 spl set id: b69917c0-95d5-4b29-b0e3-07054a4fd79f unii: JTE4MNN1MD
Azithromycin	AZITHROMYCIN MONOHYDRATE	Fresenius Kabi USA, LLC	9ad099d5-5c57-4855-98a4-e03fb4629dbf	2024-10-11	Warnings, Adverse reactions	Exact identifier application number: ANDA065179 ndc (package): 63323-398-14 ndc (package): 63323-398-41 ndc (product): 63323-398 rxcui: 1668238 spl id: 68f27342-2536-4b06-95f5-24ae83ba7e12 spl set id: 9ad099d5-5c57-4855-98a4-e03fb4629dbf unii: JTE4MNN1MD
Azithromycin	AZITHROMYCIN MONOHYDRATE	Sagent Pharmaceuticals	6497fb5e-82d8-4411-b994-7ee01333ffd7	2024-09-19	Warnings, Adverse reactions	Exact identifier rxcui: 1668238 unii: JTE4MNN1MD
AZASITE	AZITHROMYCIN MONOHYDRATE	Thea Pharma Inc.	0c5d6f5e-18ea-436f-8c62-bbaf66effe3d	2024-07-25	Warnings, Adverse reactions	Exact identifier unii: JTE4MNN1MD
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	549cdd0a-da79-23b8-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Exact identifier unii: JTE4MNN1MD
AZITHROMYCIN	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	90a506cd-aae7-a622-e053-2a95a90ad352	2024-06-19	Warnings, Adverse reactions	Exact identifier unii: JTE4MNN1MD
AZITHROMYCIN	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	82454fb2-e524-ecb8-e053-2991aa0a6e7c	2024-06-14	Warnings, Adverse reactions	Exact identifier unii: JTE4MNN1MD
AZITHROMYCIN	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	8389c336-25eb-a96f-e053-2a91aa0a0dd8	2024-06-14	Warnings, Adverse reactions	Exact identifier unii: JTE4MNN1MD
Sodium Citrate and Citric Acid	SODIUM CITRATE AND CITRIC ACID	Chartwell RX, LLC	525136c9-7758-437b-b57b-94b905786825	2024-05-31	Adverse reactions	Exact identifier unii: 2968PHW8QP
Azithromycin	AZITHROMYCIN	Chartwell RX, LLC	2c9de2e9-c20c-4660-a272-a22019f9fb02	2024-04-09	Warnings, Adverse reactions	Exact identifier unii: JTE4MNN1MD
Azithromycin	AZITHROMYCIN	Proficient Rx LP	44134421-cb0b-4e85-a3c8-d58bdb476fad	2024-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: JTE4MNN1MD
Azithromycin	AZITHROMYCIN	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	2b821631-0df2-0fb2-e054-00144ff8d46c	2024-02-29	Warnings, Adverse reactions	Exact identifier unii: JTE4MNN1MD
Oracit	CITRIC ACID AND SODIUM CITRATE	CMP Pharma, Inc.	bc26abed-8e6e-475d-8ab3-abf7d0377003	2023-12-07	Adverse reactions	Exact identifier unii: 2968PHW8QP
Phexxi	LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE	Evofem, Inc.	173ff411-7227-47b0-94dc-844e1ebaf14e	2023-11-21	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	2023-09-01	Warnings, Adverse reactions	Exact identifier unii: JTE4MNN1MD
Azithromycin	AZITHROMYCIN	Teva Pharmaceuticals USA, Inc.	f6a52c0b-45db-422e-8c22-e867a11b4439	2023-03-01	Warnings, Adverse reactions	Exact identifier unii: JTE4MNN1MD
Azithromycin	AZITHROMYCIN DIHYDRATE	Slate Run Pharmaceuticals	8acce3c1-f4be-4968-a71f-3ffd9fbaa4a4	2022-12-01	Warnings, Adverse reactions	Exact identifier rxcui: 1668238

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.