FDA.reportPublic FDA data

Ibuprofen

Product NDC
46122-580
11-digit product format
461220580
Labeler code
46122
Product ID
46122-580_513b4b7a-b59f-0abc-e063-6294a90a59ae
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
AMERISOURCE BERGEN
Application
ANDA078682
Marketing category
ANDA
Marketing start
2019-03-01
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
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
46122-580-41Ibuprofen80 in 1 CARTONCAPSULE, LIQUID FILLED807
46122-580-41Ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED807
46122-580-55Ibuprofen120 in 1 BOTTLECAPSULE, LIQUID FILLED1207
46122-580-58Ibuprofen40 in 1 CARTONCAPSULE, LIQUID FILLED407
46122-580-58Ibuprofen40 in 1 BOTTLECAPSULE, LIQUID FILLED407

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-580-41EA - Each46122-580112487d2-4732-4d5c-ae22-c101eb9f719312021-09-07
46122-580-55EA - Each46122-5803ed74b41-b71b-4e9c-bc21-f7994500262412020-06-05
46122-580-58EA - Each46122-58045a251c3-0431-4c1b-87a9-7929325a1be812021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-580IBUPROFEN CAPSULE, LIQUID FILLED [AMERISOURCE BERGEN]4Current NDC, Legacy NDC, 5 package rows20221220_1afcf0c6-bd41-4621-9e44-d97b81221c12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN1afcf0c6-bd41-4621-9e44-d97b81221c127
310964ibuprofen 200 MG Oral CapsuleSCD1afcf0c6-bd41-4621-9e44-d97b81221c127

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-580-414612205804180 BOTTLE in 1 CARTON (46122-580-41) > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE80 bottle2019-09-040000-00-00NoNoCurrent
46122-580-5546122058055120 CAPSULE, LIQUID FILLED in 1 BOTTLE (46122-580-55) 2019-03-010000-00-00NoNoCurrent
46122-580-584612205805840 BOTTLE in 1 CARTON (46122-580-58) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE40 bottle2019-09-040000-00-00NoNoCurrent