Home NDC 49483-600 IBUPROFEN
Product NDC 49483-600
11-digit product format 494830600
Labeler code 49483
Product ID 49483-600_375d8923-4e92-d631-e063-6294a90a20eb
Type HUMAN OTC DRUG
Nonproprietary name IBUPFROFEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler TIME CAP LABORATORIES,INC
Application ANDA091239
Marketing category ANDA
Marketing start 2016-03-22
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 49483-600-01 IBUPROFEN 100 in 1 BOTTLE TABLET, FILM COATED 100 12 49483-600-05 IBUPROFEN 50 in 1 BOTTLE TABLET, FILM COATED 50 12 49483-600-50 IBUPROFEN 500 in 1 BOTTLE TABLET, FILM COATED 500 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-600 IBUPROFEN TABLET, FILM COATED IBUPROFEN TABLET, FILM COATED IBUPROFEN (IBUPFROFEN) TABLET, FILM COATED [TIME CAP LABORATORIES,INC] 11 Current NDC, Legacy NDC, 3 package rows 20231123_f58d35f9-e44b-417b-98ce-0766b537cd2f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49483-600-01 49483060001 100 TABLET, FILM COATED in 1 BOTTLE (49483-600-01) 2016-03-22 0000-00-00 No No Current 49483-600-05 49483060005 50 TABLET, FILM COATED in 1 BOTTLE (49483-600-05) 2016-03-22 0000-00-00 No No Current 49483-600-50 49483060050 500 TABLET, FILM COATED in 1 BOTTLE (49483-600-50) 2017-11-14 0000-00-00 No No Current