FDA.reportPublic FDA data

IBUPROFEN

Product NDC
29485-9291
11-digit product format
294859291
Labeler code
29485
Product ID
29485-9291_1b4465c6-4eb5-1258-e063-6394a90a6db4
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN 200MG
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
ANDA075010
Marketing category
ANDA
Marketing start
2017-05-02
Marketing end
2027-06-18
Substance
IBUPROFEN
Active strength
200 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
IBUPROFEN

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29485-9291-2IBUPROFEN2 in 1 POUCHTABLET, FILM COATED28
29485-9291-2IBUPROFEN25 in 1 BOXTABLET, FILM COATED258
29485-9291-3IBUPROFEN30 in 1 BOXTABLET, FILM COATED308
29485-9291-3IBUPROFEN2 in 1 POUCHTABLET, FILM COATED28
29485-9291-5IBUPROFEN50 in 1 BOXTABLET, FILM COATED508
29485-9291-5IBUPROFEN2 in 1 POUCHTABLET, FILM COATED28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-9291IBUPROFEN (IBUPROFEN 200MG) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]8Current NDC, Legacy NDC, 6 package rows20240621_8fc65767-1783-4f7f-8680-9e43ba4d5481.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN8fc65767-1783-4f7f-8680-9e43ba4d54818
310965ibuprofen 200 MG Oral TabletSCD8fc65767-1783-4f7f-8680-9e43ba4d54818
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY8fc65767-1783-4f7f-8680-9e43ba4d54818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29485-9291-22948592910225 POUCH in 1 BOX (29485-9291-2) > 2 TABLET, FILM COATED in 1 POUCH25 pouch2017-05-020000-00-00NoNoCurrent
29485-9291-32948592910330 POUCH in 1 BOX (29485-9291-3) / 2 TABLET, FILM COATED in 1 POUCH30 pouch2017-05-022027-06-18NoNoCurrent
29485-9291-52948592910550 POUCH in 1 BOX (29485-9291-5) / 2 TABLET, FILM COATED in 1 POUCH50 pouch2017-05-022027-06-18NoNoCurrent