Home NDC 37808-609-11 Ibuprofen
Product NDC 37808-609
Requested package NDC 37808-609-11
11-digit product format 378080609
Labeler code 37808
Product ID 37808-609_3bca0ef3-e546-28a9-e063-6294a90a4fb8
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler HEB
Application ANDA078682
Marketing category ANDA
Marketing start 2021-09-24
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 A078682-001 IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24
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 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 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 3 · 60 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2027-12-31 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 310964 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 37808-609-11 Ibuprofen 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 5 37808-609-11 Ibuprofen 20 in 1 BOTTLE CAPSULE, LIQUID FILLED 20 5 37808-609-78 Ibuprofen 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 5 37808-609-78 Ibuprofen 80 in 1 BOTTLE CAPSULE, LIQUID FILLED 80 5 37808-609-83 Ibuprofen 300 in 1 BOTTLE CAPSULE, LIQUID FILLED 300 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-609 IBUPROFEN CAPSULE, LIQUID FILLED [HEB] 4 Current NDC, Legacy NDC, 5 package rows 20221229_ca4be24c-5d92-ddc9-e053-2a95a90aa5a7.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 37808-609-11 37808060911 1 BOTTLE in 1 CARTON (37808-609-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2021-09-24 0000-00-00 No No Current