Ibuprofen

Product NDC
53746-464
11-digit product format
537460464
Labeler code
53746
Product ID
53746-464_769cfd1d-35d7-4f1a-ad8b-1bf642e02075
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
Substance
IBUPROFEN
Active strength
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805, 197806, 197807

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
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
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
53746-464-01Ibuprofen100 in 1 BOTTLETABLET10026
53746-464-05Ibuprofen500 in 1 BOTTLETABLET50026
53746-464-30Ibuprofen30 in 1 BOTTLETABLET3026
53746-464-60Ibuprofen60 in 1 BOTTLETABLET6026
53746-464-90Ibuprofen90 in 1 BOTTLETABLET9026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-464-01EA - Each53746-46451570e0c-db69-4475-a0de-153b3adafd1a12012-07-24
53746-464-05EA - Each53746-4641277ce17-cc74-4a33-8458-58e5fdbe836e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [PROFICIENT RX LP]4
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [PROFICIENT RX LP]4
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]3
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]3
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [AIDAREX PHARMACEUTICALS LLC]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [DISPENSING SOLUTIONS, INC.]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [DISPENSING SOLUTIONS, INC.]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [AIDAREX PHARMACEUTICALS LLC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]2
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [MEDSOURCE PHARMACEUTICALS]1
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [ALTURA PHARMACEUTICALS, INC.]1
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [DIRECT RX]1
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN (IBUPROFEN) TABLET [H.J. HARKINS COMPANY, INC.]1
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [MEDVANTX, INC.]1
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [REBEL DISTRIBUTORS CORP]1
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [REDPHARM DRUG INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [REDPHARM DRUG INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [ALTURA PHARMACEUTICALS, INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [MEDSOURCE PHARMACEUTICALS]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [DIRECT RX]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [REBEL DISTRIBUTORS CORP]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN (IBUPROFEN) TABLET [H.J. HARKINS COMPANY, INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [MEDVANTX, INC.]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [REDPHARM DRUG INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [REDPHARM DRUG INC.]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [REDPHARM DRUG INC.]1
polyvinyl alcoholINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET [REDPHARM DRUG INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [REDPHARM DRUG INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [REDPHARM DRUG INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [REDPHARM DRUG INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [REDPHARM DRUG INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [REDPHARM DRUG INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-464IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]26Current NDC, Legacy NDC, 5 package rows20241222_faebc392-0fd9-4c71-8471-beba10dda022.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNfaebc392-0fd9-4c71-8471-beba10dda02226
197806ibuprofen 600 MG Oral TabletPSNfaebc392-0fd9-4c71-8471-beba10dda02226
197807ibuprofen 800 MG Oral TabletPSNfaebc392-0fd9-4c71-8471-beba10dda02226
197805ibuprofen 400 MG Oral TabletSCDfaebc392-0fd9-4c71-8471-beba10dda02226
197806ibuprofen 600 MG Oral TabletSCDfaebc392-0fd9-4c71-8471-beba10dda02226
197807ibuprofen 800 MG Oral TabletSCDfaebc392-0fd9-4c71-8471-beba10dda02226
197805ibuprofen 400 MG Oral TabletPSNe23eb275-ce0c-40ec-b809-a48c5e46c7ec9
197806ibuprofen 600 MG Oral TabletPSNe23eb275-ce0c-40ec-b809-a48c5e46c7ec9
197807ibuprofen 800 MG Oral TabletPSNe23eb275-ce0c-40ec-b809-a48c5e46c7ec9
197805ibuprofen 400 MG Oral TabletSCDe23eb275-ce0c-40ec-b809-a48c5e46c7ec9
197806ibuprofen 600 MG Oral TabletSCDe23eb275-ce0c-40ec-b809-a48c5e46c7ec9
197807ibuprofen 800 MG Oral TabletSCDe23eb275-ce0c-40ec-b809-a48c5e46c7ec9
197805ibuprofen 400 MG Oral TabletPSN207ebbc7-eae4-45f3-9ae3-4845479632ad7
197806ibuprofen 600 MG Oral TabletPSN207ebbc7-eae4-45f3-9ae3-4845479632ad7
197807ibuprofen 800 MG Oral TabletPSN207ebbc7-eae4-45f3-9ae3-4845479632ad7
197805ibuprofen 400 MG Oral TabletSCD207ebbc7-eae4-45f3-9ae3-4845479632ad7
197806ibuprofen 600 MG Oral TabletSCD207ebbc7-eae4-45f3-9ae3-4845479632ad7
197807ibuprofen 800 MG Oral TabletSCD207ebbc7-eae4-45f3-9ae3-4845479632ad7
197805ibuprofen 400 MG Oral TabletPSNe31d4be3-e542-43a1-a6e3-4f6937a003ae4
197806ibuprofen 600 MG Oral TabletPSNe31d4be3-e542-43a1-a6e3-4f6937a003ae4
197807ibuprofen 800 MG Oral TabletPSNe31d4be3-e542-43a1-a6e3-4f6937a003ae4
197805ibuprofen 400 MG Oral TabletSCDe31d4be3-e542-43a1-a6e3-4f6937a003ae4
197806ibuprofen 600 MG Oral TabletSCDe31d4be3-e542-43a1-a6e3-4f6937a003ae4
197807ibuprofen 800 MG Oral TabletSCDe31d4be3-e542-43a1-a6e3-4f6937a003ae4
197805ibuprofen 400 MG Oral TabletPSNec090526-a623-4e65-8b63-916c492372753
197805ibuprofen 400 MG Oral TabletSCDec090526-a623-4e65-8b63-916c492372753
197805ibuprofen 400 MG Oral TabletPSNb6847040-4624-449b-bff5-c3cd0f5786c12
197805ibuprofen 400 MG Oral TabletPSNc22b75cb-c744-4233-bbf8-b220526daad82
197805ibuprofen 400 MG Oral TabletPSNaee5ffdc-0fe4-4a74-8b0a-7009d72c35062
197805ibuprofen 400 MG Oral TabletPSN187eb9c7-3c96-4bb0-b3fc-d4aaded34d3c2
197805ibuprofen 400 MG Oral TabletPSN1ddb2839-218a-2176-e054-00144ff88e882
197805ibuprofen 400 MG Oral TabletPSN8a187e32-4db8-4cd2-b619-f97c9b312d5a2
197806ibuprofen 600 MG Oral TabletPSNaee5ffdc-0fe4-4a74-8b0a-7009d72c35062
197806ibuprofen 600 MG Oral TabletPSN187eb9c7-3c96-4bb0-b3fc-d4aaded34d3c2
197806ibuprofen 600 MG Oral TabletPSN8a187e32-4db8-4cd2-b619-f97c9b312d5a2
197806ibuprofen 600 MG Oral TabletPSNc22b75cb-c744-4233-bbf8-b220526daad82
197806ibuprofen 600 MG Oral TabletPSNb6847040-4624-449b-bff5-c3cd0f5786c12
197807ibuprofen 800 MG Oral TabletPSNc22b75cb-c744-4233-bbf8-b220526daad82
197807ibuprofen 800 MG Oral TabletPSNb6847040-4624-449b-bff5-c3cd0f5786c12
197807ibuprofen 800 MG Oral TabletPSNaee5ffdc-0fe4-4a74-8b0a-7009d72c35062
197807ibuprofen 800 MG Oral TabletPSN8a187e32-4db8-4cd2-b619-f97c9b312d5a2
197805ibuprofen 400 MG Oral TabletSCD187eb9c7-3c96-4bb0-b3fc-d4aaded34d3c2
197805ibuprofen 400 MG Oral TabletSCDaee5ffdc-0fe4-4a74-8b0a-7009d72c35062
197805ibuprofen 400 MG Oral TabletSCDc22b75cb-c744-4233-bbf8-b220526daad82
197805ibuprofen 400 MG Oral TabletSCD1ddb2839-218a-2176-e054-00144ff88e882
197805ibuprofen 400 MG Oral TabletSCDb6847040-4624-449b-bff5-c3cd0f5786c12
197805ibuprofen 400 MG Oral TabletSCD8a187e32-4db8-4cd2-b619-f97c9b312d5a2
197806ibuprofen 600 MG Oral TabletSCDaee5ffdc-0fe4-4a74-8b0a-7009d72c35062
197806ibuprofen 600 MG Oral TabletSCD187eb9c7-3c96-4bb0-b3fc-d4aaded34d3c2
197806ibuprofen 600 MG Oral TabletSCDb6847040-4624-449b-bff5-c3cd0f5786c12
197806ibuprofen 600 MG Oral TabletSCD8a187e32-4db8-4cd2-b619-f97c9b312d5a2
197806ibuprofen 600 MG Oral TabletSCDc22b75cb-c744-4233-bbf8-b220526daad82
197807ibuprofen 800 MG Oral TabletSCDaee5ffdc-0fe4-4a74-8b0a-7009d72c35062
197807ibuprofen 800 MG Oral TabletSCDc22b75cb-c744-4233-bbf8-b220526daad82
197807ibuprofen 800 MG Oral TabletSCDb6847040-4624-449b-bff5-c3cd0f5786c12
197807ibuprofen 800 MG Oral TabletSCD8a187e32-4db8-4cd2-b619-f97c9b312d5a2
197805ibuprofen 400 MG Oral TabletPSNcb5a45c6-b192-452a-a8d6-cd29636b66ea1
197805ibuprofen 400 MG Oral TabletPSNc6c3b8b0-4932-4cee-af0b-f14425925c501
197805ibuprofen 400 MG Oral TabletPSN940f3140-fe00-4297-ba81-f49bc3a3ace01
197805ibuprofen 400 MG Oral TabletPSNb98da58b-8245-44ae-b617-c4404f1305f01
197805ibuprofen 400 MG Oral TabletPSN5acccf6e-a393-67e5-e053-2a91aa0afb981
197806ibuprofen 600 MG Oral TabletPSN940f3140-fe00-4297-ba81-f49bc3a3ace01
197806ibuprofen 600 MG Oral TabletPSNc6c3b8b0-4932-4cee-af0b-f14425925c501
197807ibuprofen 800 MG Oral TabletPSN940f3140-fe00-4297-ba81-f49bc3a3ace01
197807ibuprofen 800 MG Oral TabletPSNc6c3b8b0-4932-4cee-af0b-f14425925c501
197805ibuprofen 400 MG Oral TabletSCDb98da58b-8245-44ae-b617-c4404f1305f01
197805ibuprofen 400 MG Oral TabletSCD5acccf6e-a393-67e5-e053-2a91aa0afb981
197805ibuprofen 400 MG Oral TabletSCDc6c3b8b0-4932-4cee-af0b-f14425925c501
197805ibuprofen 400 MG Oral TabletSCD940f3140-fe00-4297-ba81-f49bc3a3ace01
197805ibuprofen 400 MG Oral TabletSCDcb5a45c6-b192-452a-a8d6-cd29636b66ea1
197806ibuprofen 600 MG Oral TabletSCDc6c3b8b0-4932-4cee-af0b-f14425925c501
197806ibuprofen 600 MG Oral TabletSCD940f3140-fe00-4297-ba81-f49bc3a3ace01
197807ibuprofen 800 MG Oral TabletSCDc6c3b8b0-4932-4cee-af0b-f14425925c501
197807ibuprofen 800 MG Oral TabletSCD940f3140-fe00-4297-ba81-f49bc3a3ace01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-464-0153746046401100 TABLET in 1 BOTTLE (53746-464-01) 100 tablet2009-11-230000-00-00NoNoCurrent
53746-464-0553746046405500 TABLET in 1 BOTTLE (53746-464-05) 500 tablet2009-11-230000-00-00NoNoCurrent
53746-464-305374604643030 TABLET in 1 BOTTLE (53746-464-30) 30 tablet2009-11-230000-00-00NoNoCurrent
53746-464-605374604646060 TABLET in 1 BOTTLE (53746-464-60) 60 tablet2009-11-230000-00-00NoNoCurrent
53746-464-905374604649090 TABLET in 1 BOTTLE (53746-464-90) 90 tablet2009-11-230000-00-00NoNoCurrent