FDA.reportPublic FDA data

Acetylcysteine

Product NDC
70594-111
11-digit product format
705940111
Labeler code
70594
Product ID
70594-111_bfb03f99-1389-424a-a457-efbb23f198ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetylcysteine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA217182
Marketing category
ANDA
Marketing start
2023-06-10
Substance
ACETYLCYSTEINE
Active strength
200 mg/mL
Pharmacologic classes
Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetylcysteine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETYLCYSTEINE200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWYQ7N0BPYC
Rxcui465377

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
465377acetylcysteine 6 GM in 30 ML InjectionPSN3e2e187e-2445-43b1-b66c-b828e2adf0222
46537730 ML acetylcysteine 200 MG/ML InjectionSCD3e2e187e-2445-43b1-b66c-b828e2adf0222
465377acetylcysteine 6 GM per 30 ML InjectionSY3e2e187e-2445-43b1-b66c-b828e2adf0222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70594-111-017059401110130 mL in 1 VIAL30 mlHistorical
70594-111-02705940111024 VIAL in 1 CARTON (70594-111-02) / 30 mL in 1 VIAL (70594-111-01) 4 vial2023-06-10NoNoHistorical