Ibuprofen

Product NDC
55700-445
11-digit product format
557000445
Labeler code
55700
Product ID
55700-445_c1af9352-c277-499c-9e24-ef955e0ac013
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
600 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-445-00EA - Each55700-4454f8609c9-c513-4afb-a700-c1ef2b7770f012016-12-07
55700-445-20EA - Each55700-4458051b4da-591a-4a4c-977e-4c3e9d00d47412016-12-07
55700-445-30EA - Each55700-445be7ba74a-c0df-4a3c-99e4-bd55d409aebd12016-12-07
55700-445-40EA - Each55700-445bddc7d92-431f-48da-834a-14fcafeddfd312016-12-07
55700-445-60EA - Each55700-4457654d779-675d-4117-baa6-936ac83f20a412016-12-07
55700-445-90EA - Each55700-4457dbb6e0b-8dda-4d3c-a340-b0c01c52d21c12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-445IBUPROFEN TABLET, FILM COATED [QUALITY CARE PRODUCTS LLC]10Legacy NDC20241219_e9a5f214-a387-4429-a875-eb1e9aa714c1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-445-0055700044500100 TABLET, FILM COATED in 1 BOTTLE (55700-445-00) 2016-10-170000-00-00NoNoCurrent
55700-445-205570004452020 TABLET, FILM COATED in 1 BOTTLE (55700-445-20) 2016-10-170000-00-00NoNoCurrent
55700-445-305570004453030 TABLET, FILM COATED in 1 BOTTLE (55700-445-30) 2016-10-170000-00-00NoNoCurrent
55700-445-405570004454040 TABLET, FILM COATED in 1 BOTTLE (55700-445-40) 2016-10-170000-00-00NoNoCurrent
55700-445-605570004456060 TABLET, FILM COATED in 1 BOTTLE (55700-445-60) 2016-10-170000-00-00NoNoCurrent
55700-445-905570004459090 TABLET, FILM COATED in 1 BOTTLE (55700-445-90) 2016-10-170000-00-00NoNoCurrent