FDA.reportPublic FDA data

NDC 81565-202-01 - Dexamethasone Sodium Phosphate

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
81565-202
Requested NDC
81565-202-01
Package NDCs from labels
81565-202-01, 81565-202-02
Manufacturer
Phlow Corporation | Fresenius Kabi USA, LLC
Effective date
2024-06-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexamethasone Sodium Phosphate - Phlow Corporation | Fresenius Kabi USA, LLCPhlow Corporation | Fresenius Kabi USA, LLC2024-06-25HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81565-202-022024-02-22C16284748780-11030e365-69e4-111a-e063-dadaa90a10e2Dexamethasone Sodium Phosphate Injection, USP
81565-202-022024-01-30C16284748780-11030e365-69e4-111a-e063-dadaa90a10e2Dexamethasone Sodium Phosphate Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81565-202-01Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION, SOLUTION13
81565-202-02Dexamethasone Sodium Phosphate25 in 1 TRAYINJECTION, SOLUTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81565-202DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) INJECTION, SOLUTION [PHLOW CORPORATION]3Current NDC, Legacy NDC, 2 package rows20240704_02d25ab8-8f51-452b-b944-f569fbae36fe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81565-202-01ML - Milliliter81565-202d4cc6f4d-866e-400a-9c10-2cf1604a187e12022-05-04
81565-202-02ML - Milliliter81565-202b73bdd71-4a09-4d7b-9332-e09f8691f1fb12022-05-04

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 1 of 17 · 325 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEREMEDYREPACK INC.11f10a47-1c42-40e4-89d8-bb000fef497c2026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 1812194
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLC9822a5c3-d3f1-4e0b-9963-32b22740e10e2026-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA084916
unii: AI9376Y64P
Dexamethasone sodium phosphateDEXAMETHASONE SODIUM PHOSPHATEMicro Labs Limitedc6f2563b-5a39-48bf-bcfe-71dd417bd9702026-08-26Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEASCLEMED USA INC.a31b013f-924c-42f8-b8ab-ce60bb8ad7b82026-08-07Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESagent Pharmaceuticals4680d517-ed5a-4137-819c-122ee962a4642026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 1812194
unii: AI9376Y64P
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLCa8aee11f-c928-41ef-8df8-e6d8b355536c2026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 1812194
unii: AI9376Y64P
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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