FDA.reportPublic FDA data

Ibuprofen

Product NDC
69367-396
11-digit product format
693670396
Labeler code
69367
Product ID
69367-396_786c8d96-734d-4905-ae64-490c41bfbf40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA202413
Marketing category
ANDA
Marketing start
2024-05-23
Substance
IBUPROFEN
Active strength
800 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
IBUPROFEN800 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
69367-396-01Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1002
69367-396-05Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-396IBUPROFEN TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20241030_eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNab2f1a30-611b-41b6-9baf-6a82305da8456
197807ibuprofen 800 MG Oral TabletSCDab2f1a30-611b-41b6-9baf-6a82305da8456
197807ibuprofen 800 MG Oral TabletPSN2e0f74a5-b8f3-fc81-e063-6394a90a647a5
197807ibuprofen 800 MG Oral TabletSCD2e0f74a5-b8f3-fc81-e063-6394a90a647a5
197807ibuprofen 800 MG Oral TabletPSN404df13d-4ada-4324-9eed-e21f5d5043a44
197807ibuprofen 800 MG Oral TabletSCD404df13d-4ada-4324-9eed-e21f5d5043a44
197807ibuprofen 800 MG Oral TabletPSN0170876a-d8cd-4a2d-8397-db2acdf72ffb3
197807ibuprofen 800 MG Oral TabletPSN2d0c2d35-c212-4daa-b2c4-b407ca0b16ad3
197807ibuprofen 800 MG Oral TabletSCD2d0c2d35-c212-4daa-b2c4-b407ca0b16ad3
197807ibuprofen 800 MG Oral TabletSCD0170876a-d8cd-4a2d-8397-db2acdf72ffb3
197805ibuprofen 400 MG Oral TabletPSNeeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d2
197806ibuprofen 600 MG Oral TabletPSNeeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d2
197807ibuprofen 800 MG Oral TabletPSN4e67aef4-c3ac-232a-e063-6394a90a3a852
197807ibuprofen 800 MG Oral TabletPSNeeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d2
197807ibuprofen 800 MG Oral TabletPSNb84ea215-e61d-4c00-8a34-d47c4080779b2
197807ibuprofen 800 MG Oral TabletPSN44f278ac-6bf9-6aef-e063-6394a90a0bb62
197807ibuprofen 800 MG Oral TabletPSN3b17587e-b609-42a9-e063-6294a90ab1f82
197805ibuprofen 400 MG Oral TabletSCDeeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d2
197806ibuprofen 600 MG Oral TabletSCDeeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d2
197807ibuprofen 800 MG Oral TabletSCD3b17587e-b609-42a9-e063-6294a90ab1f82
197807ibuprofen 800 MG Oral TabletSCD44f278ac-6bf9-6aef-e063-6394a90a0bb62
197807ibuprofen 800 MG Oral TabletSCD4e67aef4-c3ac-232a-e063-6394a90a3a852
197807ibuprofen 800 MG Oral TabletSCDeeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d2
197807ibuprofen 800 MG Oral TabletSCDb84ea215-e61d-4c00-8a34-d47c4080779b2
197805ibuprofen 400 MG Oral TabletPSNca81671d-1ea8-4c67-802f-adb3a2f087cc1
197806ibuprofen 600 MG Oral TabletPSNca81671d-1ea8-4c67-802f-adb3a2f087cc1
197807ibuprofen 800 MG Oral TabletPSN2dcbe4bb-fb24-e827-e063-6394a90acf9f1
197807ibuprofen 800 MG Oral TabletPSN0ce79e85-0b8b-436e-b895-ea5c02eaf4ba1
197807ibuprofen 800 MG Oral TabletPSNca81671d-1ea8-4c67-802f-adb3a2f087cc1
197807ibuprofen 800 MG Oral TabletPSN410f7320-4caa-8f88-e063-6394a90acf931
197807ibuprofen 800 MG Oral TabletPSNb0917020-f0ec-4d07-8fbf-c1eb909f466b1
197807ibuprofen 800 MG Oral TabletPSN34673d3b-41cd-f4c9-e063-6394a90a85101
197807ibuprofen 800 MG Oral TabletPSN8d41cc03-dec6-4949-b7c1-7deb2897e2c41
197805ibuprofen 400 MG Oral TabletSCDca81671d-1ea8-4c67-802f-adb3a2f087cc1
197806ibuprofen 600 MG Oral TabletSCDca81671d-1ea8-4c67-802f-adb3a2f087cc1
197807ibuprofen 800 MG Oral TabletSCDb0917020-f0ec-4d07-8fbf-c1eb909f466b1
197807ibuprofen 800 MG Oral TabletSCDca81671d-1ea8-4c67-802f-adb3a2f087cc1
197807ibuprofen 800 MG Oral TabletSCD2dcbe4bb-fb24-e827-e063-6394a90acf9f1
197807ibuprofen 800 MG Oral TabletSCD34673d3b-41cd-f4c9-e063-6394a90a85101
197807ibuprofen 800 MG Oral TabletSCD8d41cc03-dec6-4949-b7c1-7deb2897e2c41
197807ibuprofen 800 MG Oral TabletSCD0ce79e85-0b8b-436e-b895-ea5c02eaf4ba1
197807ibuprofen 800 MG Oral TabletSCD410f7320-4caa-8f88-e063-6394a90acf931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-396-0169367039601100 TABLET, FILM COATED in 1 BOTTLE (69367-396-01) 2024-05-23NoNoCurrent
69367-396-0569367039605500 TABLET, FILM COATED in 1 BOTTLE (69367-396-05) 2024-05-23NoNoCurrent