Home NDC 55305-133 AeroTab Ibuprofen
Product NDC 55305-133
11-digit product format 553050133
Labeler code 55305
Product ID 55305-133_2f179532-9c6f-6ed3-e063-6294a90ab2b7
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen tablet
Dosage form TABLET, COATED
Route ORAL
Labeler Aero Healthcare
Application ANDA091239
Marketing category ANDA
Marketing start 2018-01-01
Substance IBUPROFEN
Active strength 200 mg/1000mg
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 AeroTab Ibuprofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1000mg
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55305-133-01 AeroTab Ibuprofen 2 mg in 1 PACKET TABLET, COATED 2 2 55305-133-02 AeroTab Ibuprofen 25 in 1 BOX TABLET, COATED 25 2 55305-133-03 AeroTab Ibuprofen 25 in 1 BOX TABLET, COATED 25 2 55305-133-04 AeroTab Ibuprofen 50 in 1 BOX TABLET, COATED 50 2 55305-133-05 AeroTab Ibuprofen 125 in 1 BOX TABLET, COATED 125 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55305-133 AEROTAB IBUPROFEN (IBUPROFEN TABLET) TABLET, COATED [AERO HEALTHCARE] 2 Current NDC, Legacy NDC, 5 package rows 20250228_ddd0f7fb-ae4b-c584-e053-2a95a90a0984.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 55305-133-01 55305013301 2 mg in 1 PACKET 2 mg Historical 55305-133-02 55305013302 25 PACKET in 1 BOX (55305-133-02) / 2 mg in 1 PACKET (55305-133-01) 25 packet 2018-01-01 0000-00-00 No No Current 55305-133-03 55305013303 25 PACKET in 1 BOX (55305-133-03) / 2 mg in 1 PACKET (55305-133-01) 25 packet 2018-01-01 0000-00-00 No No Current 55305-133-04 55305013304 50 PACKET in 1 BOX (55305-133-04) / 2 mg in 1 PACKET (55305-133-01) 50 packet 2018-01-01 0000-00-00 No No Current 55305-133-05 55305013305 125 PACKET in 1 BOX (55305-133-05) / 2 mg in 1 PACKET (55305-133-01) 125 packet 2018-01-01 0000-00-00 No No Current