FDA.reportPublic FDA data

Ibuprofen

Product NDC
21130-261
11-digit product format
211300261
Labeler code
21130
Product ID
21130-261_06b97e58-9021-f781-e063-6394a90ab2ca
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
BETTER LIVING BRANDS, LLC
Application
ANDA091239
Marketing category
ANDA
Marketing start
2023-06-12
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
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
21130-261-01Ibuprofen1 in 1 CARTONTABLET15
21130-261-01Ibuprofen100 in 1 BOTTLETABLET1005
21130-261-05Ibuprofen50 in 1 BOTTLETABLET505
21130-261-05Ibuprofen1 in 1 CARTONTABLET15
21130-261-42Ibuprofen1 in 1 CARTONTABLET15
21130-261-42Ibuprofen24 in 1 BOTTLETABLET245
21130-261-53Ibuprofen500 in 1 BOTTLETABLET5005
21130-261-54Ibuprofen250 in 1 BOTTLETABLET2505
21130-261-56Ibuprofen1000 in 1 BOTTLETABLET10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-261IBUPROFEN TABLET [BETTER LIVING BRANDS, LLC]5Current NDC, 9 package rows20231003_eb613c44-e125-0f40-e053-2995a90a7ca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNeb613c44-e125-0f40-e053-2995a90a7ca55
310965ibuprofen 200 MG Oral TabletSCDeb613c44-e125-0f40-e053-2995a90a7ca55
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYeb613c44-e125-0f40-e053-2995a90a7ca55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-261-01211300261011 BOTTLE in 1 CARTON (21130-261-01) / 100 TABLET in 1 BOTTLE1 bottle2023-08-30NoNoCurrent
21130-261-05211300261051 BOTTLE in 1 CARTON (21130-261-05) / 50 TABLET in 1 BOTTLE1 bottle2023-08-30NoNoCurrent
21130-261-42211300261421 BOTTLE in 1 CARTON (21130-261-42) / 24 TABLET in 1 BOTTLE1 bottle2023-09-15NoNoCurrent
21130-261-5321130026153500 TABLET in 1 BOTTLE (21130-261-53) 500 tablet2023-06-12NoNoCurrent
21130-261-5421130026154250 TABLET in 1 BOTTLE (21130-261-54) 250 tablet2023-06-12NoNoCurrent
21130-261-56211300261561000 TABLET in 1 BOTTLE (21130-261-56) 1000 tablet2023-06-22NoNoCurrent