Home NDC 66424-396 Ibuprofen
Product NDC 66424-396
11-digit product format 664240396
Labeler code 66424
Product ID 66424-396_729d0c91-8063-484e-b6d4-d110dd0aa93e
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler SDA Laboratories, Inc.
Application ANDA091239
Marketing category ANDA
Marketing start 2016-03-01
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66424-396-10 Ibuprofen 1000 in 1 BOTTLE, PLASTIC TABLET 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66424-396 IBUPROFEN TABLET [SDA LABORATORIES, INC.] 1 Legacy NDC, 1 package rows 20160302_1c1e72fd-0c88-4220-a972-2419b118d9c6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 66424-396-10 66424039610 1000 in 1 BOTTLE, PLASTIC Historical