FDA.reportPublic FDA data

IBUPROFEN

Product NDC
61919-683
11-digit product format
619190683
Labeler code
61919
Product ID
61919-683_f21620df-a19b-7df4-e053-2995a90a00c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA091625
Marketing category
ANDA
Marketing start
2020-06-16
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
400 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
2024-12-31
Current FDA listing
Historical FDA.report record

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
61919-683-302025-01-30C16284748780-12cef2736-84e9-d83d-e063-dadaa90ab31fibuprofen
61919-683-602025-01-30C16284748780-12cef2736-84e9-d83d-e063-dadaa90ab31fibuprofen
61919-683-902025-01-30C16284748780-12cef2736-84e9-d83d-e063-dadaa90ab31fibuprofen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-683-30IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED308
61919-683-60IBUPROFEN60 in 1 BOTTLETABLET, FILM COATED608
61919-683-90IBUPROFEN90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-683-30EA - Each61919-68317a8f5f6-6114-4c69-87c7-081907ae659b12020-07-13
61919-683-60EA - Each61919-6835df510c4-38f7-49a2-bee0-754a2cf707e212020-07-13
61919-683-90EA - Each61919-683adc0b6f7-e39f-474f-b146-9a57a2d396b812020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-683IBUPROFEN TABLET IBUPROFEN TABLET, FILM COATED [DIRECT_RX]8Legacy NDC, 3 package rows20230113_908e725f-bd99-6d0b-e053-2995a90aefb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN908e725f-bd99-6d0b-e053-2995a90aefb28
197806ibuprofen 600 MG Oral TabletPSN908e725f-bd99-6d0b-e053-2995a90aefb28
197805ibuprofen 400 MG Oral TabletSCD908e725f-bd99-6d0b-e053-2995a90aefb28
197806ibuprofen 600 MG Oral TabletSCD908e725f-bd99-6d0b-e053-2995a90aefb28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-683-306191906833030 TABLET, FILM COATED in 1 BOTTLE (61919-683-30) 2022-09-270000-00-00NoNoCurrent
61919-683-606191906836060 TABLET, FILM COATED in 1 BOTTLE (61919-683-60) 2022-09-270000-00-00NoNoCurrent
61919-683-906191906839090 TABLET, FILM COATED in 1 BOTTLE (61919-683-90) 2022-09-270000-00-00NoNoCurrent