FDA.reportPublic FDA data

NDC 70594-111-01 - Acetylcysteine

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
70594-111
Requested NDC
70594-111-01
Package NDCs from labels
70594-111-01, 70594-111-02
Manufacturer
Xellia Pharmaceuticals USA LLC
Effective date
2023-05-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acetylcysteine - Xellia Pharmaceuticals USA LLCXellia Pharmaceuticals USA LLC2023-05-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-111-01Acetylcysteine30 mL in 1 VIALINJECTION, SOLUTION302
70594-111-02Acetylcysteine4 in 1 CARTONINJECTION, SOLUTION42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-111ACETYLCYSTEINE INJECTION, SOLUTION [XELLIA PHARMACEUTICALS USA LLC]2Current NDC, 2 package rows20230621_3e2e187e-2445-43b1-b66c-b828e2adf022.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-111-01ML - Milliliter70594-11171c23865-11aa-494a-afb3-2b4a225ddab912023-09-05
70594-111-02ML - Milliliter70594-111aa5adcd2-ba0b-4aa9-8771-45e3ad0aa50212023-09-05

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FolcyteineMULTIVITAMINPureTek Corporation04cf0026-e29b-ffd5-e063-6294a90aca1f2026-07-08Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEHospira, Inc.5558a5f5-e821-473b-7d8a-5d33d09f05862026-05-22Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEGlenmark Pharmaceuticals Inc., USAf811ddfc-d7c1-4637-ae81-80c38a77cb802026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINESomerset Therapeutics, LLCd50c8ab6-26f8-4669-89d1-c4d26698159a2026-04-11Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINECardinal Health 107, LLCc90fca12-12fb-4cf6-bd6f-83bc0d95df812026-04-07Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEEugia US LLC5ae53725-1abb-4122-9c85-f26c2c31566c2025-12-02Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINESagent Pharmaceuticalsc206c659-16ea-444a-8c60-8a3343400ada2025-10-26Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEONESOURCE SPECIALTY PHARMA LIMITED3b0310d2-4e70-4b94-8d69-cb5999a32b542025-09-12Warnings, Adverse reactionsExact identifier
application number: ANDA217182
rxcui: 465377
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEHikma Pharmaceuticals USA Inc.277963a0-8ab2-4305-a688-28e47e87c5842025-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA217182
rxcui: 465377
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINECameron Pharmaceuticals8165ad85-98e7-438f-9567-5cfda88d0ebf2025-08-26Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
acetylcysteineACETYLCYSTEINEPadagis US LLC9d305722-e74f-4f48-8d2c-0daa991447492025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
ACETADOTEACETYLCYSTEINECumberland Pharmaceuticals Inc.472f158a-5ab9-4308-8e49-1116e6ea3d392025-04-30Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEAmerican Regent, Inc.f56b4087-db48-4fd7-84ec-9c927962b8052024-12-17Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC75b48fab-cef6-465c-a1e0-d085b3988bc42024-08-15Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINESomerset Therapeutics, LLCb8d3ed96-d7ee-43f4-986c-a7d04808711a2024-06-13Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
ANTI AGE STRESSACETYLCYSTEINE - BALLOTA FOETIDA - EPINEPHRINE - GLUTATHIONE - INTERFERON GAMMA-1B - LENOGRASTIM - LITHIUM CARBONATE - MELATONIN - PENICILLIUM GLABRUM - POTASSIUM CARBONATE - PUMMELO - RHODOTORULA RUBRA - SILVER NITRATE - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA CEREBRAL CORTEX - SUS SCROFA STOMACH - SUS SCROFA SUPERIOR GASTRIC PLEXUS - SUS SCROFA THALAMUS -Guna space25f3c5-20c9-4ba8-ac58-546febf142ec2023-11-02WarningsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEXellia Pharmaceuticals USA LLC3e2e187e-2445-43b1-b66c-b828e2adf0222023-05-31Warnings, Adverse reactionsExact identifier
application number: ANDA217182
ndc (package): 70594-111-02
ndc (package): 70594-111-01
ndc (product): 70594-111
ndc11 (package): 70594011101
rxcui: 465377
spl id: bfb03f99-1389-424a-a457-efbb23f198ee
spl set id: 3e2e187e-2445-43b1-b66c-b828e2adf022
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC8cca4e4c-85a2-d575-e053-2995a90a65992022-10-31Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLCd990ef51-ced2-4359-b99b-092334d2dc9b2022-10-31Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC8d81039e-20ef-5144-e053-2a95a90a89fd2022-10-31Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC

Reported adverse events (FAERS/openFDA)#

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