AMAZON BASIC CARE IBUPROFEN PM

Product NDC
72288-061
11-digit product format
722880061
Labeler code
72288
Product ID
72288-061_b56bbd9c-6f93-4563-9d2b-ec458829f025
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen and Diphenhydramine Citrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA216204
Marketing category
ANDA
Marketing start
2024-05-15
Substance
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength
38; 200 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMAZON BASIC CARE IBUPROFEN PM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE CITRATE38 mg/1
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4OD433S209, WK2XYI10QM
Rxcui895664

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-061-77AMAZON BASIC CARE IBUPROFEN PM120 in 1 BOTTLETABLET, COATED1203
72288-061-77AMAZON BASIC CARE IBUPROFEN PM1 in 1 CARTONTABLET, COATED13
72288-061-80AMAZON BASIC CARE IBUPROFEN PM80 in 1 BOTTLETABLET, COATED803
72288-061-80AMAZON BASIC CARE IBUPROFEN PM1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-061AMAZON BASIC CARE IBUPROFEN PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [AMAZON.COM SERVICES LLC]2Current NDC, 4 package rows20240515_10ec6386-db13-a9dd-e063-6294a90a8261.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN10ec6386-db13-a9dd-e063-6294a90a82613
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD10ec6386-db13-a9dd-e063-6294a90a82613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-061-77722880061771 BOTTLE in 1 CARTON (72288-061-77) / 120 TABLET, COATED in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-061-80722880061801 BOTTLE in 1 CARTON (72288-061-80) / 80 TABLET, COATED in 1 BOTTLE1 bottle2026-03-18NoNoCurrent