FDA.reportPublic FDA data

Ibuprofen minis

Product NDC
21130-843
11-digit product format
211300843
Labeler code
21130
Product ID
21130-843_3d94c1de-f7a7-4fed-beae-041b92c7782f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Safeway, Inc.
Application
ANDA206568
Marketing category
ANDA
Marketing start
2018-12-05
Marketing end
2026-12-05
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen minis

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-843-16Ibuprofen minis160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1607
21130-843-16Ibuprofen minis1 in 1 BOXCAPSULE, LIQUID FILLED17
21130-843-80Ibuprofen minis1 in 1 BOXCAPSULE, LIQUID FILLED17
21130-843-80Ibuprofen minis80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-843IBUPROFEN MINIS (IBUPROFEN) CAPSULE, LIQUID FILLED [SAFEWAY, INC.]6Current NDC, Legacy NDC, 4 package rows20240327_22927a12-6837-4d57-8e60-043000f2f208.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN22927a12-6837-4d57-8e60-043000f2f2087
310964ibuprofen 200 MG Oral CapsuleSCD22927a12-6837-4d57-8e60-043000f2f2087

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-843-16211300843161 BOTTLE, PLASTIC in 1 BOX (21130-843-16) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-12-052026-12-05NoNoCurrent
21130-843-80211300843801 BOTTLE, PLASTIC in 1 BOX (21130-843-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-12-052026-12-05NoNoCurrent