FDA.reportPublic FDA data

up and up ibuprofen pm

Product NDC
11673-050
11-digit product format
116730050
Labeler code
11673
Product ID
11673-050_85dc1973-d04b-4c7e-a5c4-24c94a791a05
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate and ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Target Corporation
Application
ANDA079113
Marketing category
ANDA
Marketing start
2009-07-10
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
up and up 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
11673-050-27up and up ibuprofen pm80 in 1 BOTTLETABLET, FILM COATED8012
11673-050-27up and up ibuprofen pm1 in 1 CARTONTABLET, FILM COATED112
11673-050-58up and up ibuprofen pm40 in 1 BOTTLETABLET, FILM COATED4012
11673-050-58up and up ibuprofen pm1 in 1 CARTONTABLET, FILM COATED112
11673-050-60up and up ibuprofen pm1 in 1 CARTONTABLET, FILM COATED112
11673-050-60up and up ibuprofen pm20 in 1 BOTTLETABLET, FILM COATED2012
11673-050-76up and up ibuprofen pm120 in 1 BOTTLETABLET, FILM COATED12012
11673-050-76up and up ibuprofen pm1 in 1 CARTONTABLET, FILM COATED112
11673-050-82up and up ibuprofen pm200 in 1 BOTTLETABLET, FILM COATED20012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11673-050-27EA - Each11673-0507e4850f0-a663-43a6-8aea-be586567b32712012-07-24
11673-050-58EA - Each11673-050b231717c-3640-4813-8346-6f13f44833cd12012-07-24
11673-050-76EA - Each11673-050bda6ec35-41ca-4a24-ade5-c3dea43e4b6012019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209UP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
IBUPROFENACTIVE INGREDIENTWK2XYI10QMUP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MUP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
IBUPROFENACTIVE MOIETYWK2XYI10QMUP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UUP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48UP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357UP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2UP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PUP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XUP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30UP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AUP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990UP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4UP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
TALCINACTIVE INGREDIENT7SEV7J4R1UUP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TARGET CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-050UP AND UP IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, FILM COATED [TARGET CORPORATION]10Current NDC, Legacy NDC, 9 package rows20240206_0c764683-f3c9-4382-96be-d34b7a582aee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN0c764683-f3c9-4382-96be-d34b7a582aee12
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD0c764683-f3c9-4382-96be-d34b7a582aee12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-050-27116730050271 BOTTLE in 1 CARTON (11673-050-27) > 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-07-100000-00-00NoNoCurrent
11673-050-58116730050581 BOTTLE in 1 CARTON (11673-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-07-240000-00-00NoNoCurrent
11673-050-60116730050601 BOTTLE in 1 CARTON (11673-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2026-03-10NoNoHistorical
11673-050-76116730050761 BOTTLE in 1 CARTON (11673-050-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-02-070000-00-00NoNoCurrent
11673-050-8211673005082200 TABLET, FILM COATED in 1 BOTTLE (11673-050-82) 2022-01-270000-00-00NoNoCurrent