FDA.reportPublic FDA data

Ibuprofen

Product NDC
55700-634
11-digit product format
557000634
Labeler code
55700
Product ID
55700-634_ce41cb11-f6fd-4989-b260-962b5a93aa2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA202413
Marketing category
ANDA
Marketing start
2018-05-25
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
600 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-634-20EA - Each55700-6342a53a4e3-d4af-4f99-9558-690727cd906312018-06-11
55700-634-30EA - Each55700-634b6cd0c0d-16ee-407a-aa63-fd34f5ea960912018-06-11
55700-634-40EA - Each55700-634e4aa8967-3d57-4227-beec-35723406f44112018-06-11
55700-634-60EA - Each55700-634d70a8063-9d39-46b2-ab83-1ab6bdcaa6e312018-06-11
55700-634-90EA - Each55700-634937a3648-689b-4970-aeca-1ee73c2b3a8b12018-06-11