FDA.reportPublic FDA data

Acetaminophen

Product NDC
70038-131
11-digit product format
700380131
Labeler code
70038
Product ID
70038-131_4652d772-fe08-2ce4-e063-6294a90a1ddd
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RAONBIO CORP
Application
ANDA216592
Marketing category
ANDA
Marketing start
2024-01-01
Substance
ACETAMINOPHEN; IBUPROFEN
Active strength
250; 125 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
IBUPROFEN125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, WK2XYI10QM
Rxcui2387532

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70038-131-36Acetaminophen36 in 1 BOTTLETABLET366
70038-131-72Acetaminophen72 in 1 BOTTLETABLET726
70038-131-81Acetaminophen18 in 1 BOTTLETABLET186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70038-131ACETAMINOPHEN TABLET [RAONBIO CORP]4Current NDC, 3 package rows20241218_f6f5251d-db89-4b69-e053-6394a90a1028.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNf6f5251d-db89-4b69-e053-6394a90a10286
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDf6f5251d-db89-4b69-e053-6394a90a10286
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYf6f5251d-db89-4b69-e053-6394a90a10286

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70038-131-367003801313636 TABLET in 1 BOTTLE (70038-131-36) 36 tablet2024-01-01NoNoCurrent
70038-131-727003801317272 TABLET in 1 BOTTLE (70038-131-72) 72 tablet2024-01-01NoNoCurrent
70038-131-817003801318118 TABLET in 1 BOTTLE (70038-131-81) 18 tablet2024-01-01NoNoCurrent