FDA.reportPublic FDA data

Ibuprofen

Product NDC
55312-218
11-digit product format
553120218
Labeler code
55312
Product ID
55312-218_7ddacf90-6468-4342-837c-fe4330f5a7ea
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Western Family Foods, Inc.
Application
ANDA079174
Marketing category
ANDA
Marketing start
2012-07-05
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55312-218-102020-01-31C16284748780-19d75b9d0-6763-f424-e053-dadaa90a57ceDRUG FACTS
55312-218-242020-01-31C16284748780-19d75b9d0-6763-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55312-218-10Ibuprofen1 in 1 BOXTABLET12
55312-218-10Ibuprofen100 in 1 BOTTLETABLET1002
55312-218-24Ibuprofen1 in 1 BOXTABLET12
55312-218-24Ibuprofen24 in 1 BOTTLETABLET242

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55312-218IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]2Legacy NDC, 4 package rows20121016_523bef75-c20a-4cfd-8d31-725bafae6df8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN523bef75-c20a-4cfd-8d31-725bafae6df82
310965ibuprofen 200 MG Oral TabletSCD523bef75-c20a-4cfd-8d31-725bafae6df82
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY523bef75-c20a-4cfd-8d31-725bafae6df82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55312-218-10553120218101 in 1 BOXHistorical
55312-218-24553120218241 in 1 BOXHistorical