FDA.reportPublic FDA data

Ibuprofen

Product NDC
55319-252
11-digit product format
553190252
Labeler code
55319
Product ID
55319-252_9b1330f8-4f89-4542-b53b-b5770763be5f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
ANDA079129
Marketing category
ANDA
Marketing start
2023-09-15
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

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
55319-252-05Ibuprofen500 in 1 BOTTLETABLET, COATED5008
55319-252-10Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, COATED1008
55319-252-10Ibuprofen1 in 1 BOXTABLET, COATED18
55319-252-24Ibuprofen1 in 1 BOXTABLET, COATED18
55319-252-24Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, COATED248
55319-252-25Ibuprofen250 in 1 BOTTLE, PLASTICTABLET, COATED2508
55319-252-25Ibuprofen1 in 1 BOXTABLET, COATED18
55319-252-50Ibuprofen1 in 1 BOXTABLET, COATED18
55319-252-50Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, COATED508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-252IBUPROFEN TABLET, COATED [FAMILY DOLLAR (FAMILY WELLNESS)]5Current NDC, 9 package rows20250417_da16b1a9-0db2-4f2f-bc85-05ea5ab26e1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNda16b1a9-0db2-4f2f-bc85-05ea5ab26e1c8
310965ibuprofen 200 MG Oral TabletSCDda16b1a9-0db2-4f2f-bc85-05ea5ab26e1c8
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYda16b1a9-0db2-4f2f-bc85-05ea5ab26e1c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55319-252-0555319025205500 TABLET, COATED in 1 BOTTLE (55319-252-05) 2023-09-15NoNoCurrent
55319-252-10553190252101 BOTTLE, PLASTIC in 1 BOX (55319-252-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2023-09-15NoNoCurrent
55319-252-24553190252241 BOTTLE, PLASTIC in 1 BOX (55319-252-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2023-09-15NoNoCurrent
55319-252-25553190252251 BOTTLE, PLASTIC in 1 BOX (55319-252-25) / 250 TABLET, COATED in 1 BOTTLE, PLASTIC2023-09-15NoNoCurrent
55319-252-50553190252501 BOTTLE, PLASTIC in 1 BOX (55319-252-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2023-09-15NoNoCurrent