IBU

Product NDC
51407-369
11-digit product format
514070369
Labeler code
51407
Product ID
51407-369_4f74413b-a528-1a18-e063-6294a90a7d99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075682
Marketing category
ANDA
Marketing start
2001-11-14
Marketing end
2027-08-31
Substance
IBUPROFEN
Active strength
400 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IBU

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-369-05IBU500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-369-05EA - Each51407-369dd3597ea-e32b-450a-b535-b5d2e72137bc12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-369IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4Current NDC, Legacy NDC, 1 package rows20241213_bbf4821d-f9fc-9f6e-e053-2a95a90a5253.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-369-0551407036905500 TABLET in 1 BOTTLE (51407-369-05) 500 tablet2021-02-222027-08-31NoNoCurrent