IBU

Product NDC
35356-699
11-digit product format
353560699
Labeler code
35356
Product ID
35356-699_9f8ffb4b-d185-4908-8793-4f6e617405f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA075682
Marketing category
ANDA
Marketing start
2008-11-20
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
600 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35356-699-002021-02-09C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-202021-02-09C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-212021-02-09C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-282021-02-09C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-302021-02-09C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-402021-02-09C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-602021-02-09C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-902021-02-09C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-002021-01-29C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-202021-01-29C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-212021-01-29C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-282021-01-29C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-302021-01-29C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-402021-01-29C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-602021-01-29C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636
35356-699-902021-01-29C16284748780-1ba0f9c33-250c-a910-e053-dadaa90a0b854655ae9b-27d6-44fb-a932-92f33a1a6636

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-699-00EA - Each35356-6996184e150-ec82-4bc1-99ba-3e7eedefe2e012013-02-13
35356-699-20EA - Each35356-699f4c4b6e9-661c-4f5f-b42a-27cb6f1e40be12013-02-13
35356-699-30EA - Each35356-699b701c362-20e1-44de-b3ae-06b4c71fc6c312017-09-11
35356-699-40EA - Each35356-699f41d633d-97f1-485c-91f3-bda183fee46512018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMIBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242
IbuprofenACTIVE MOIETYWK2XYI10QMIBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242
carnauba waxINACTIVE INGREDIENTR12CBM0EIZIBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UIBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242
hypromellosesINACTIVE INGREDIENT3NXW29V3WOIBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242
magnesium stearateINACTIVE INGREDIENT70097M6I30IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242
polydextroseINACTIVE INGREDIENTVH2XOU12IEIBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQIBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HIBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPIBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35356-699IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]32459Legacy NDC20241222_4655ae9b-27d6-44fb-a932-92f33a1a6636.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-699-0035356069900100 TABLET in 1 BOTTLE (35356-699-00) 100 tablet2008-11-200000-00-00NoNoCurrent
35356-699-203535606992020 TABLET in 1 BOTTLE (35356-699-20) 20 tablet2008-11-200000-00-00NoNoCurrent
35356-699-213535606992121 TABLET in 1 BOTTLE (35356-699-21) 21 tablet2008-11-200000-00-00NoNoCurrent
35356-699-283535606992828 TABLET in 1 BOTTLE (35356-699-28) 28 tablet2008-11-200000-00-00NoNoCurrent
35356-699-303535606993030 TABLET in 1 BOTTLE (35356-699-30) 30 tablet2008-11-200000-00-00NoNoCurrent
35356-699-403535606994040 TABLET in 1 BOTTLE (35356-699-40) 40 tablet2008-11-200000-00-00NoNoCurrent
35356-699-603535606996060 TABLET in 1 BOTTLE (35356-699-60) 60 tablet2008-11-200000-00-00NoNoCurrent
35356-699-903535606999090 TABLET in 1 BOTTLE (35356-699-90) 90 tablet2008-11-200000-00-00NoNoCurrent