Home NDC 52605-114 Ibuprofen
Product NDC 52605-114
11-digit product format 526050114
Labeler code 52605
Product ID 52605-114_c265106e-3575-4073-8195-0aa0adb10f45
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, COATED
Route ORAL
Labeler Polygen Pharmaceuticals LLC
Application ANDA091239
Marketing category ANDA
Marketing start 2012-06-05
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 200 mg/1
NDC exclude flag E
Listing certified through 2017-12-31
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 52605-114-01 Ibuprofen 1 in 1 CARTON TABLET, COATED 1 6 52605-114-01 Ibuprofen 100 in 1 BOTTLE TABLET, COATED 100 6 52605-114-10 Ibuprofen 1000 in 1 BOTTLE TABLET, COATED 1000 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52605-114 IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] 6 Legacy NDC, 3 package rows 20130627_00bc1e01-f90e-444d-b7d6-807797a1d136.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52605-114-01 52605011401 1 in 1 CARTON Historical 52605-114-10 52605011410 1000 in 1 BOTTLE Historical