acetaminophen

Product NDC
68071-4172
11-digit product format
680714172
Labeler code
68071
Product ID
68071-4172_1a3b93c2-3a06-fd40-e063-6394a90a6635
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA070607
Marketing category
ANDA
Marketing start
2010-12-14
Substance
ACETAMINOPHEN
Active strength
120 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acetaminophen
Brand name suffix
for children
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198434

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4172-6acetaminophenfor children6 in 1 BLISTER PACKSUPPOSITORY65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4172ACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240608_5f86e792-3262-4ee6-e053-2991aa0a54a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198434acetaminophen 120 MG Rectal SuppositoryPSN5f86e792-3262-4ee6-e053-2991aa0a54a05
198434acetaminophen 120 MG Rectal SuppositorySCD5f86e792-3262-4ee6-e053-2991aa0a54a05
198434APAP 120 MG Rectal SuppositorySY5f86e792-3262-4ee6-e053-2991aa0a54a05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4172-6680714172066 SUPPOSITORY in 1 BLISTER PACK (68071-4172-6) 6 suppository2017-12-040000-00-00NoNoCurrent