FDA.reportPublic FDA data

Acetylcysteine

Product NDC
68462-946
11-digit product format
684620946
Labeler code
68462
Product ID
68462-946_9a22e853-f45c-4bda-87e1-5aaf8e61a225
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetylcysteine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA213693
Marketing category
ANDA
Marketing start
2024-09-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetylcysteine
Listing expiration
2027-12-31

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
68462-946-12Acetylcysteine4 in 1 CARTONINJECTION, SOLUTION43
68462-946-30Acetylcysteine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-946-12ML - Milliliter68462-946c6de0c83-2953-4440-a80f-8fef56b2cf0112025-05-14
68462-946-30ML - Milliliter68462-9461f6a2748-15a9-400a-9927-a5f8671ca66a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-946ACETYLCYSTEINE INJECTION, SOLUTION [GLENMARK PHARMACEUTICALS INC., USA]2Current NDC, 2 package rows20250326_f811ddfc-d7c1-4637-ae81-80c38a77cb80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
465377acetylcysteine 6 GM in 30 ML InjectionPSNf811ddfc-d7c1-4637-ae81-80c38a77cb803
46537730 ML acetylcysteine 200 MG/ML InjectionSCDf811ddfc-d7c1-4637-ae81-80c38a77cb803
465377acetylcysteine 6 GM per 30 ML InjectionSYf811ddfc-d7c1-4637-ae81-80c38a77cb803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-946-12684620946124 VIAL, SINGLE-DOSE in 1 CARTON (68462-946-12) / 30 mL in 1 VIAL, SINGLE-DOSE (68462-946-30) 2024-09-25NoNoHistorical
68462-946-306846209463030 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical