FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
AeroTab Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1000mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55305-133-022025-02-26C16284748780-11030e365-55f5-111a-e063-dadaa90a10e2AeroTab Ibuprofen Tablets
55305-133-032025-02-26C16284748780-11030e365-55f5-111a-e063-dadaa90a10e2AeroTab Ibuprofen Tablets
55305-133-042025-02-26C16284748780-11030e365-55f5-111a-e063-dadaa90a10e2AeroTab Ibuprofen Tablets
55305-133-052025-02-26C16284748780-11030e365-55f5-111a-e063-dadaa90a10e2AeroTab Ibuprofen Tablets
55305-133-022024-01-30C16284748780-11030e365-55f5-111a-e063-dadaa90a10e2AeroTab Ibuprofen Tablets
55305-133-032024-01-30C16284748780-11030e365-55f5-111a-e063-dadaa90a10e2AeroTab Ibuprofen Tablets
55305-133-042024-01-30C16284748780-11030e365-55f5-111a-e063-dadaa90a10e2AeroTab Ibuprofen Tablets
55305-133-052024-01-30C16284748780-11030e365-55f5-111a-e063-dadaa90a10e2AeroTab Ibuprofen Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55305-133-01AeroTab Ibuprofen2 mg in 1 PACKETTABLET, COATED22
55305-133-02AeroTab Ibuprofen25 in 1 BOXTABLET, COATED252
55305-133-03AeroTab Ibuprofen25 in 1 BOXTABLET, COATED252
55305-133-04AeroTab Ibuprofen50 in 1 BOXTABLET, COATED502
55305-133-05AeroTab Ibuprofen125 in 1 BOXTABLET, COATED1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55305-133AEROTAB IBUPROFEN (IBUPROFEN TABLET) TABLET, COATED [AERO HEALTHCARE]2Current NDC, Legacy NDC, 5 package rows20250228_ddd0f7fb-ae4b-c584-e053-2a95a90a0984.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNddd0f7fb-ae4b-c584-e053-2a95a90a09842
310965ibuprofen 200 MG Oral TabletSCDddd0f7fb-ae4b-c584-e053-2a95a90a09842
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYddd0f7fb-ae4b-c584-e053-2a95a90a09842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55305-133-01553050133012 mg in 1 PACKET2 mgHistorical
55305-133-025530501330225 PACKET in 1 BOX (55305-133-02) / 2 mg in 1 PACKET (55305-133-01) 25 packet2018-01-010000-00-00NoNoCurrent
55305-133-035530501330325 PACKET in 1 BOX (55305-133-03) / 2 mg in 1 PACKET (55305-133-01) 25 packet2018-01-010000-00-00NoNoCurrent
55305-133-045530501330450 PACKET in 1 BOX (55305-133-04) / 2 mg in 1 PACKET (55305-133-01) 50 packet2018-01-010000-00-00NoNoCurrent
55305-133-0555305013305125 PACKET in 1 BOX (55305-133-05) / 2 mg in 1 PACKET (55305-133-01) 125 packet2018-01-010000-00-00NoNoCurrent