FDA.reportPublic FDA data

Ibuprofen

Product NDC
21130-359
11-digit product format
211300359
Labeler code
21130
Product ID
21130-359_f6f317d8-a7c2-2ba3-e053-6394a90a5db0
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
BETTER LIVING BRANDS LLC.
Application
ANDA202312
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
21130-359-052023-03-16C16284748780-1f386c64a-1b96-0266-e053-dadaa90a7c1aIbuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* See New Warnings
21130-359-102023-03-16C16284748780-1f386c64a-1b96-0266-e053-dadaa90a7c1aIbuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* See New Warnings
21130-359-052023-01-30C16284748780-1f386c64a-1b96-0266-e053-dadaa90a7c1aIbuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* See New Warnings
21130-359-102023-01-30C16284748780-1f386c64a-1b96-0266-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
21130-359-05Ibuprofen50 in 1 BOTTLETABLET, COATED503
21130-359-10Ibuprofen100 in 1 BOTTLETABLET, COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-359IBUPROFEN TABLET, COATED [BETTER LIVING BRANDS LLC.]3Current NDC, Legacy NDC, 2 package rows20230317_a3fadcc0-97f5-9f9b-e053-2a95a90aeb54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNa3fadcc0-97f5-9f9b-e053-2a95a90aeb543
310965ibuprofen 200 MG Oral TabletSCDa3fadcc0-97f5-9f9b-e053-2a95a90aeb543
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYa3fadcc0-97f5-9f9b-e053-2a95a90aeb543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-359-052113003590550 TABLET, COATED in 1 BOTTLE (21130-359-05) 2020-08-010000-00-00NoNoCurrent
21130-359-1021130035910100 TABLET, COATED in 1 BOTTLE (21130-359-10) 2020-08-010000-00-00NoNoCurrent