FDA.reportPublic FDA data

Ibuprofen

Product NDC
62207-366
11-digit product format
622070366
Labeler code
62207
Product ID
62207-366_f37b04a6-8c5f-0644-e053-2995a90a40a0
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Granules India Limited
Application
ANDA079174
Marketing category
ANDA
Marketing start
2011-01-01
Substance
IBUPROFEN
Active strength
200 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
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62207-366-41Ibuprofen24 in 1 BOTTLETABLET2418
62207-366-42Ibuprofen50 in 1 BOTTLETABLET5018
62207-366-43Ibuprofen100 in 1 BOTTLETABLET10018
62207-366-46Ibuprofen250 in 1 BOTTLETABLET25018
62207-366-47Ibuprofen500 in 1 BOTTLETABLET50018
62207-366-48Ibuprofen750 in 1 BOTTLETABLET75018
62207-366-49Ibuprofen1000 in 1 BOTTLETABLET100018
62207-366-51Ibuprofen10 in 1 BOTTLETABLET1018

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311IBUPROFEN TABLET [GRANULES INDIA LIMITED]11
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET [GRANULES INDIA LIMITED]11
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62IBUPROFEN TABLET [GRANULES INDIA LIMITED]11
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
POVIDONE K30INACTIVE INGREDIENTU725QWY32XIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [GRANULES INDIA LIMITED]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET [GRANULES INDIA LIMITED]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
TRIACETININACTIVE INGREDIENTXHX3C3X673IBUPROFEN TABLET [GRANULES INDIA LIMITED]11
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
62207-366IBUPROFEN TABLET [GRANULES INDIA LIMITED]18Current NDC, Legacy NDC, 8 package rows20230131_fd01353d-1d1d-42b5-9a03-575052189bf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNfd01353d-1d1d-42b5-9a03-575052189bf518
310965ibuprofen 200 MG Oral TabletSCDfd01353d-1d1d-42b5-9a03-575052189bf518
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYfd01353d-1d1d-42b5-9a03-575052189bf518
310965ibuprofen 200 MG Oral TabletPSNbaa437dd-b89d-44d9-9a05-5438499331272
310965ibuprofen 200 MG Oral TabletSCDbaa437dd-b89d-44d9-9a05-5438499331272
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYbaa437dd-b89d-44d9-9a05-5438499331272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62207-366-416220703664124 TABLET in 1 BOTTLE (62207-366-41) 24 tablet2019-08-130000-00-00NoNoCurrent
62207-366-426220703664250 TABLET in 1 BOTTLE (62207-366-42) 50 tablet2019-08-130000-00-00NoNoCurrent
62207-366-4362207036643100 TABLET in 1 BOTTLE (62207-366-43) 100 tablet2019-08-130000-00-00NoNoCurrent
62207-366-4662207036646250 TABLET in 1 BOTTLE (62207-366-46) 250 tablet2019-08-130000-00-00NoNoCurrent
62207-366-4762207036647500 TABLET in 1 BOTTLE (62207-366-47) 500 tablet2019-08-130000-00-00NoNoCurrent
62207-366-4862207036648750 TABLET in 1 BOTTLE (62207-366-48) 750 tablet2019-08-130000-00-00NoNoCurrent
62207-366-49622070366491000 TABLET in 1 BOTTLE (62207-366-49) 1000 tablet2019-08-130000-00-00NoNoCurrent
62207-366-516220703665110 TABLET in 1 BOTTLE (62207-366-51) 10 tablet2019-08-130000-00-00NoNoCurrent