FDA.reportPublic FDA data

NDC 0409-3308-11 - 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
0409-3308
Requested NDC
0409-3308-11
Package NDCs from labels
0409-3308-11, 0409-3308-03
Manufacturer
Hospira, Inc.
Effective date
2026-05-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACETYLCYSTEINE Solution, USP 10% and 20% Teartop VialsHospira, Inc.2026-05-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3308-03Acetylcysteine3 in 1 CARTONSOLUTION322
0409-3308-11Acetylcysteine30 mL in 1 VIALSOLUTION3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3308ACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]20Current NDC, Legacy NDC, 2 package rows20241018_5558a5f5-e821-473b-7d8a-5d33d09f0586.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3308-03ML - Milliliter0409-33089f06ae0d-a023-4f62-a3d7-b9c1df415e6512012-07-24
0409-3308-11ML - Milliliter0409-33083776bbdb-4b7e-48b1-a56a-b87bd9fc19b312020-09-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETYLCYSTEINEACTIVE INGREDIENTWYQ7N0BPYCACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]13
ACETYLCYSTEINEACTIVE MOIETYWYQ7N0BPYCACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]13
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]13

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 3 · 55 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
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
AcetylcysteineACETYLCYSTEINEHospira, Inc.5558a5f5-e821-473b-7d8a-5d33d09f05862026-05-22Warnings, Adverse reactionsExact identifier
application number: ANDA073664
application number: ANDA074037
ndc (package): 0409-3308-03
ndc (package): 0409-3308-11
ndc (package): 0409-3307-03
ndc (package): 0409-3307-11
ndc (product): 0409-3308
ndc (product): 0409-3307
ndc11 (package): 00409330811
rxcui: 307718
rxcui: 307719
spl id: 6c12470d-0f1a-4085-938d-121df34c3cb0
spl set id: 5558a5f5-e821-473b-7d8a-5d33d09f0586
unii: WYQ7N0BPYC
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
AcetylcysteineACETYLCYSTEINEGlenmark Pharmaceuticals Inc., USAf811ddfc-d7c1-4637-ae81-80c38a77cb802026-05-06Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINESomerset Therapeutics, LLCd50c8ab6-26f8-4669-89d1-c4d26698159a2026-04-11Warnings, Adverse reactionsExact identifier
rxcui: 307718
rxcui: 307719
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINECardinal Health 107, LLCc90fca12-12fb-4cf6-bd6f-83bc0d95df812026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 307718
rxcui: 307719
unii: WYQ7N0BPYC
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
AcetylcysteineACETYLCYSTEINEEugia US LLC5ae53725-1abb-4122-9c85-f26c2c31566c2025-12-02Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINESagent Pharmaceuticalsc206c659-16ea-444a-8c60-8a3343400ada2025-10-26Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEONESOURCE SPECIALTY PHARMA LIMITED3b0310d2-4e70-4b94-8d69-cb5999a32b542025-09-12Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEHikma Pharmaceuticals USA Inc.277963a0-8ab2-4305-a688-28e47e87c5842025-09-09Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINECameron Pharmaceuticals8165ad85-98e7-438f-9567-5cfda88d0ebf2025-08-26Warnings, Adverse reactionsExact identifier
rxcui: 307718
rxcui: 307719
unii: WYQ7N0BPYC
acetylcysteineACETYLCYSTEINEPadagis US LLC9d305722-e74f-4f48-8d2c-0daa991447492025-07-31Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
ACETADOTEACETYLCYSTEINECumberland Pharmaceuticals Inc.472f158a-5ab9-4308-8e49-1116e6ea3d392025-04-30Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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