Home NDC 41226-600 IBUPROFEN
Product NDC 41226-600
11-digit product format 412260600
Labeler code 41226
Product ID 41226-600_3f8861cb-53a2-83f7-e063-6394a90a3879
Type HUMAN OTC DRUG
Nonproprietary name IBUPROFEN
Dosage form TABLET, COATED
Route ORAL
Labeler Kroger Company
Application ANDA091239
Marketing category ANDA
Marketing start 2021-06-12
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091239-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2011-02-01
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 16 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base IBUPROFEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310965 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41226-600-01 IBUPROFEN 1 in 1 CARTON TABLET, COATED 1 6 41226-600-01 IBUPROFEN 100 in 1 BOTTLE TABLET, COATED 100 6 41226-600-42 IBUPROFEN 1 in 1 CARTON TABLET, COATED 1 6 41226-600-42 IBUPROFEN 24 in 1 BOTTLE TABLET, COATED 24 6 41226-600-50 IBUPROFEN 500 in 1 BOTTLE TABLET, COATED 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41226-600 IBUPROFEN TABLET, COATED [KROGER COMPANY] 5 Current NDC, Legacy NDC, 5 package rows 20231230_bc173f1b-2e44-2c2e-e053-2a95a90a89c4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41226-600-01 41226060001 1 BOTTLE in 1 CARTON (41226-600-01) / 100 TABLET, COATED in 1 BOTTLE 1 bottle 2021-06-12 0000-00-00 No No Current 41226-600-42 41226060042 1 BOTTLE in 1 CARTON (41226-600-42) / 24 TABLET, COATED in 1 BOTTLE 1 bottle 2021-06-12 0000-00-00 No No Current 41226-600-50 41226060050 500 TABLET, COATED in 1 BOTTLE (41226-600-50) 2021-06-12 0000-00-00 No No Current