FDA.reportPublic FDA data

NDC 42023-216-01 - Ephedrine Sulfate

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
42023-216
Requested NDC
42023-216-01
Package NDCs from labels
42023-216-01, 42023-216-25, 42023-216-83
Manufacturer
Par Health USA, LLC
Effective date
2026-03-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ephedrine Sulfate - Par Health USA, LLCPar Health USA, LLC2026-03-17HUMAN PRESCRIPTION DRUG LABEL
Ephedrine Sulfate - Par Health USA, LLC | Endo USA, Inc.Par Health USA, LLC | Endo USA, Inc.2026-01-21HUMAN PRESCRIPTION DRUG LABEL
EPHEDRINE SULFATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-02-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-216-01Ephedrine Sulfate1 mL in 1 VIALINJECTION, SOLUTION110
42023-216-25Ephedrine Sulfate25 in 1 CARTONINJECTION, SOLUTION2510
42023-216-83Ephedrine Sulfate25 in 1 CARTONINJECTION, SOLUTION257
42023-216-83Ephedrine Sulfate1 mL in 1 VIALINJECTION, SOLUTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-216EPHEDRINE SULFATE INJECTION, SOLUTION [ENDO USA, INC.]5Current NDC, Legacy NDC, 2 package rows20240425_38723cb3-dfca-4c81-8c6f-63dd99929191.zip
42023-216EPHEDRINE SULFATE INJECTION, SOLUTION [ENDO USA, INC.]4Current NDC, Legacy NDC, 2 package rows20241018_3e43cc8e-bf4e-44ef-a07d-4336367b9bdb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-216-01ML - Milliliter42023-2166a623ae7-d3f7-4b38-9ca4-a934b31c73fb12017-03-06
42023-216-25ML - Milliliter42023-216f9d3f2b5-4cc7-44a5-b8eb-e59ce354842b12017-03-06
42023-216-83ML - Milliliter42023-2167189d2c8-1205-4d57-9be4-e8d300505cfc12018-07-03

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 2 of 10 · 197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Ephedrine sulfateEPHEDRINE SULFATENorthStar RxLLCb6fc8311-7853-4666-a1c2-668a04fe21192026-06-05Warnings, Adverse reactionsExact identifier
rxcui: 1116294
unii: U6X61U5ZEG
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ephedrine SulfateEPHEDRINE SULFATEPar Health USA, LLC38723cb3-dfca-4c81-8c6f-63dd999291912026-03-17Warnings, Adverse reactionsExact identifier
application number: NDA208943
ndc (package): 42023-216-25
ndc (package): 42023-216-01
ndc (product): 42023-216
ndc11 (package): 42023021601
rxcui: 1116294
spl id: 3aaa566f-1bff-4084-8578-60e1b66013e4
spl set id: 38723cb3-dfca-4c81-8c6f-63dd99929191
unii: U6X61U5ZEG
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Ephedrine SulfateEPHEDRINE SULFATEPar Health USA, LLC3e43cc8e-bf4e-44ef-a07d-4336367b9bdb2026-01-21Warnings, Adverse reactionsExact identifier
application number: NDA208943
ndc (package): 42023-216-83
ndc (product): 42023-216
rxcui: 1116294
spl id: 5690dbe7-c41e-4b7f-b107-e6d82b736a0f
spl set id: 3e43cc8e-bf4e-44ef-a07d-4336367b9bdb
unii: U6X61U5ZEG
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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