Home NDC 68210-0800 VALUMEDS IBUPROFEN
Product NDC 68210-0800
11-digit product format 682100800
Labeler code 68210
Product ID 68210-0800_28ed10e2-9113-a062-e063-6394a90a0ba3
Type HUMAN OTC DRUG
Nonproprietary name IBUPROFEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler SPIRIT PHARMACEUTICALS LLC
Application ANDA091239
Marketing category ANDA
Marketing start 2017-05-19
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 VALUMEDS 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 68210-0800-1 VALUMEDS IBUPROFEN 100 in 1 BOTTLE TABLET, FILM COATED 100 9 68210-0800-4 VALUMEDS IBUPROFEN 1 in 1 CARTON TABLET, FILM COATED 1 9 68210-0800-4 VALUMEDS IBUPROFEN 40 in 1 BOTTLE TABLET, FILM COATED 40 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68210-0800 VALUMEDS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC] 9 Current NDC, Legacy NDC, 3 package rows 20241212_a6d4ceb0-2b79-496a-aa1e-27edd507ced0.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 68210-0800-1 68210080001 100 TABLET, FILM COATED in 1 BOTTLE (68210-0800-1) 2017-05-19 0000-00-00 No No Current 68210-0800-4 68210080004 1 BOTTLE in 1 CARTON (68210-0800-4) / 40 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-04-11 0000-00-00 No No Current