FDA.reportPublic FDA data

Ibuprofen

Product NDC
21130-699
11-digit product format
211300699
Labeler code
21130
Product ID
21130-699_53e30a21-efc0-488c-b88a-9a35fcda3af7
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Safeway, Inc.
Application
ANDA078682
Marketing category
ANDA
Marketing start
2021-05-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

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
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
21130-699-18Ibuprofen180 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1805
21130-699-20Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED15
21130-699-20Ibuprofen20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED205
21130-699-30Ibuprofen300 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3005
21130-699-40Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED15
21130-699-40Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED405
21130-699-80Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED805
21130-699-80Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-699IBUPROFEN CAPSULE, LIQUID FILLED [SAFEWAY, INC.]4Current NDC, Legacy NDC, 8 package rows20240329_57f06daf-690d-44a7-95a5-468732949750.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN57f06daf-690d-44a7-95a5-4687329497505
310964ibuprofen 200 MG Oral CapsuleSCD57f06daf-690d-44a7-95a5-4687329497505

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-699-1821130069918180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (21130-699-18) 2021-05-282027-01-29NoNoCurrent
21130-699-20211300699201 BOTTLE, PLASTIC in 1 BOX (21130-699-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-05-280000-00-00NoNoCurrent
21130-699-3021130069930300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (21130-699-30) 2021-05-280000-00-00NoNoCurrent
21130-699-40211300699401 BOTTLE, PLASTIC in 1 BOX (21130-699-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-05-280000-00-00NoNoCurrent
21130-699-80211300699801 BOTTLE, PLASTIC in 1 BOX (21130-699-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-05-280000-00-00NoNoCurrent