Ibuprofen

Product NDC
55910-768
11-digit product format
559100768
Labeler code
55910
Product ID
55910-768_f4333107-845d-4ac6-83e4-70bcd70bb4df
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
ANDA079174
Marketing category
ANDA
Marketing start
2017-04-30
Marketing end
2026-12-30
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
55910-768-24Ibuprofen1 in 1 BOXTABLET, COATED15
55910-768-24Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, COATED245

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-768IBUPROFEN TABLET, COATED [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]4Current NDC, Legacy NDC, 2 package rows20221108_0e95aab9-3a7c-49c3-b8df-f66d6f31aee0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN0e95aab9-3a7c-49c3-b8df-f66d6f31aee05
310965ibuprofen 200 MG Oral TabletSCD0e95aab9-3a7c-49c3-b8df-f66d6f31aee05
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY0e95aab9-3a7c-49c3-b8df-f66d6f31aee05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-768-24559100768241 BOTTLE, PLASTIC in 1 BOX (55910-768-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2017-04-302026-12-30NoNoCurrent