FDA.reportPublic FDA data

Ibuprofen

Product NDC
21130-006
11-digit product format
211300006
Labeler code
21130
Product ID
21130-006_067e9eec-ba56-dc37-e063-6294a90a2df2
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
BETTER LIVING BRANDS, LLC
Application
ANDA091239
Marketing category
ANDA
Marketing start
2023-06-22
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
21130-006-01Ibuprofen100 in 1 BOTTLETABLET1003
21130-006-01Ibuprofen1 in 1 CARTONTABLET13
21130-006-05Ibuprofen1 in 1 CARTONTABLET13
21130-006-05Ibuprofen50 in 1 BOTTLETABLET503
21130-006-42Ibuprofen1 in 1 CARTONTABLET13
21130-006-42Ibuprofen24 in 1 BOTTLETABLET243
21130-006-53Ibuprofen500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-006IBUPROFEN TABLET [BETTER LIVING BRANDS, LLC]3Current NDC, 7 package rows20230930_eb60e636-41fe-49fb-e053-2a95a90a0616.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNeb60e636-41fe-49fb-e053-2a95a90a06163
310965ibuprofen 200 MG Oral TabletSCDeb60e636-41fe-49fb-e053-2a95a90a06163
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYeb60e636-41fe-49fb-e053-2a95a90a06163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-006-01211300006011 BOTTLE in 1 CARTON (21130-006-01) / 100 TABLET in 1 BOTTLE1 bottle2023-06-22NoNoCurrent
21130-006-05211300006051 BOTTLE in 1 CARTON (21130-006-05) / 50 TABLET in 1 BOTTLE1 bottle2023-09-09NoNoCurrent
21130-006-42211300006421 BOTTLE in 1 CARTON (21130-006-42) / 24 TABLET in 1 BOTTLE1 bottle2023-06-22NoNoCurrent
21130-006-5321130000653500 TABLET in 1 BOTTLE (21130-006-53) 500 tablet2023-08-28NoNoCurrent