FDA.reportPublic FDA data

Ibuprofen

Product NDC
21130-396
11-digit product format
211300396
Labeler code
21130
Product ID
21130-396_463f13c5-0ae8-3fa5-e063-6394a90afe8c
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
BETTER LIVING BRANDS LLC.
Application
ANDA079174
Marketing category
ANDA
Marketing start
2019-07-12
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-396-052023-03-02C16284748780-1f386c649-d1f8-0266-e053-dadaa90a7c1aIbuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* SEE NEW WARNINGS
21130-396-052023-01-30C16284748780-1f386c649-d1f8-0266-e053-dadaa90a7c1aIbuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* SEE NEW WARNINGS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-396-05Ibuprofen50 in 1 BOTTLETABLET506
21130-396-25Ibuprofen250 in 1 BOTTLETABLET2506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-396IBUPROFEN TABLET [BETTER LIVING BRANDS LLC.]5Current NDC, Legacy NDC, 2 package rows20241212_8c3ca03e-0ec2-c15c-e053-2995a90ad8bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN8c3ca03e-0ec2-c15c-e053-2995a90ad8bd6
310965ibuprofen 200 MG Oral TabletSCD8c3ca03e-0ec2-c15c-e053-2995a90ad8bd6
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY8c3ca03e-0ec2-c15c-e053-2995a90ad8bd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-396-052113003960550 TABLET in 1 BOTTLE (21130-396-05) 50 tablet2019-07-120000-00-00NoNoCurrent
21130-396-2521130039625250 TABLET in 1 BOTTLE (21130-396-25) 250 tablet2023-08-18NoNoHistorical